Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT00082758
Status:
COMPLETED
Last Update Posted:
2015-02-12
First Post:
2004-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
hu14.18-Interleukin-2 Fusion Protein in Treating Young Patients With Recurrent or Refractory Neuroblastoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Netherlands', 'New Zealand', 'Puerto Rico', 'Switzerland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009447', 'term': 'Neuroblastoma'}], 'ancestors': [{'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C493743', 'term': 'lorukafusp alfa'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'resultsreportingcoordinator@childrensoncologygroup.org', 'phone': '626-447-0064', 'title': 'Results Reporting Coordinator', 'organization': "Children's Oncology Group"}, 'certainAgreement': {'otherDetails': 'Must obtain prior Sponsor approval.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Duration of protocol therapy', 'description': 'Patients were evaluable for inclusion if they received at least one dose of protocol therapy. SAE field contains NCI Common Terminology Criteria for Adverse Events (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.', 'eventGroups': [{'id': 'EG000', 'title': 'Disease Measurable by Standard Criteria(hu14.18-interleukin-2)', 'description': 'Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute.\n\nhu14.18-Interleukin-2 fusion protein : Given IV', 'otherNumAtRisk': 15, 'otherNumAffected': 13, 'seriousNumAtRisk': 15, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2)', 'description': 'Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning and/or by bone marrow histology.\n\nhu14.18-Interleukin-2 fusion protein : Given IV', 'otherNumAtRisk': 24, 'otherNumAffected': 18, 'seriousNumAtRisk': 24, 'seriousNumAffected': 21}, {'id': 'EG002', 'title': 'Disease Identified by BM Immunohistochemistry Only', 'description': 'Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning or BM histology, however, disease is identified and quantified by BM immunohistochemistry (\\>5 neuroblastoma cells per 1,000,000 nucleated marrow cells).\n\nhu14.18-Interleukin-2 fusion protein : Given IV', 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 23, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 42, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Cardiac disorders - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 16, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Middle ear inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 18, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Edema face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 17, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Edema limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Edema trunk', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Localized edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'CTCv4'}, {'term': 'Alanine aminotransferase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 20, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 41, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Aspartate aminotransferase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 17, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 44, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 22, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Cholesterol high', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'GGT increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 9, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Investigations - Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 26, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Lymphocyte count decrease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 14, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 17, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 22, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 12, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'White blood cell decrease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 16, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 32, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 8, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Hypercalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 13, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 26, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Hypermagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Hypernatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Hypertriglyceridemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 20, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 45, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 17, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 38, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 8, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 17, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 14, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 11, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 27, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 20, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Intracranial hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Renal and urinary disorders, Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Allergic rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Respiratory, thoracic and mediastinal disorders, Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Voice alteration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 12, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'CTCv4'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Hearing impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Anaphylaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Bone infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Catheter related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 9, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Alanine aminotransferase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Aspartate aminotransferase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'GGT increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Lymphocyte count decrease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 33, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 20, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 27, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'White blood cell decrease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 12, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'CTCv4'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Responders (Response Rate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Disease Measurable by Standard Criteria(hu14.18-interleukin-2)', 'description': 'Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute.\n\nhu14.18-Interleukin-2 fusion protein : Given IV'}, {'id': 'OG001', 'title': 'Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2)', 'description': 'Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by MIBG (meta-iodobenzylguanidine) scanning and/or by bone marrow histology.\n\nhu14.18-Interleukin-2 fusion protein : Given IV'}, {'id': 'OG002', 'title': 'Disease Identified by BM Immunohistochemistry Only', 'description': 'Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning or BM histology, however, disease is identified and quantified by BM immunohistochemistry (\\>5 neuroblastoma cells per 1,000,000 nucleated marrow cells)\n\nhu14.18-Interleukin-2 fusion protein : Given IV'}], 'classes': [{'title': 'Responder', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Non-responder', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 30 weeks', 'description': 'Response rate to hu14.18-Interleukin-2 in 3 separate strata of patients with recurrent or refractory neuroblastoma. Patients will have radiologic (CT/MRI) tumor and urine homovanillic acid (HVA)/vanillylmandelic acid (VMA) measurements. Patients with prior marrow involvement will have marrow assessments. Patients with MIBG+ (iodine-131-meta-iodobenzylguanidine) prior disease will have MIBG scans performed. For CT/MRI lesions, measureable disease is measured by the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute. RECIST (v1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients were evaluable for inclusion in the analysis of response if eligible, had an event (relapse, PD, death or secondary malignancy) any time after enrollment, or completed at least 2 courses of Irinotecan/Temozolomide therapy. Patients off therapy before completion of 2 courses by choice or toxicity were not evaluable for response analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Disease Measurable by Standard Criteria(hu14.18-interleukin-2)', 'description': 'Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute.\n\nhu14.18-Interleukin-2 fusion protein : Given IV'}, {'id': 'FG001', 'title': 'Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2)', 'description': 'Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by meta-iodobenzylguanidine (MIBG) scanning and/or by bone marrow (BM) histology.\n\nhu14.18-Interleukin-2 fusion protein : Given IV'}, {'id': 'FG002', 'title': 'Disease Identified by BM Immunohistochemistry Only', 'description': 'Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by meta-iodobenzylguanidine (MIBG) scanning or bone marrow (BM) histology, however, disease is identified and quantified by BM immunohistochemistry (\\>5 neuroblastoma cells per 1,000,000 nucleated marrow cells)\n\nhu14.18-Interleukin-2 fusion protein : Given IV'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Disease Measurable by Standard Criteria(hu14.18-interleukin-2)', 'description': 'Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute.\n\nhu14.18-Interleukin-2 fusion protein : Given IV'}, {'id': 'BG001', 'title': 'Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2)', 'description': 'Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning and/or by bone marrow histology.\n\nhu14.18-Interleukin-2 fusion protein : Given IV'}, {'id': 'BG002', 'title': 'Disease Identified by BM Immunohistochemistry Only', 'description': 'Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning or BM histology, however, disease is identified and quantified by BM immunohistochemistry (\\>5 neuroblastoma cells per 1,000,000 nucleated marrow cells).\n\nhu14.18-Interleukin-2 fusion protein : Given IV'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'title': '<=18 years', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG003'}]}]}, {'title': 'Between 18 and 65 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '5.98', 'groupId': 'BG000', 'lowerLimit': '4.74', 'upperLimit': '10.89'}, {'value': '6.28', 'groupId': 'BG001', 'lowerLimit': '5.32', 'upperLimit': '9.09'}, {'value': '6.16', 'groupId': 'BG003', 'lowerLimit': '4.78', 'upperLimit': '9.40'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Gender', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG003'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG003'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG003'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-27', 'studyFirstSubmitDate': '2004-05-14', 'resultsFirstSubmitDate': '2013-12-02', 'studyFirstSubmitQcDate': '2004-05-18', 'lastUpdatePostDateStruct': {'date': '2015-02-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-12-02', 'studyFirstPostDateStruct': {'date': '2004-05-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Responders (Response Rate)', 'timeFrame': 'Up to 30 weeks', 'description': 'Response rate to hu14.18-Interleukin-2 in 3 separate strata of patients with recurrent or refractory neuroblastoma. Patients will have radiologic (CT/MRI) tumor and urine homovanillic acid (HVA)/vanillylmandelic acid (VMA) measurements. Patients with prior marrow involvement will have marrow assessments. Patients with MIBG+ (iodine-131-meta-iodobenzylguanidine) prior disease will have MIBG scans performed. For CT/MRI lesions, measureable disease is measured by the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute. RECIST (v1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['recurrent neuroblastoma'], 'conditions': ['Neuroblastoma']}, 'referencesModule': {'references': [{'pmid': '20935224', 'type': 'RESULT', 'citation': 'Delgado DC, Hank JA, Kolesar J, Lorentzen D, Gan J, Seo S, Kim K, Shusterman S, Gillies SD, Reisfeld RA, Yang R, Gadbaw B, DeSantes KB, London WB, Seeger RC, Maris JM, Sondel PM. Genotypes of NK cell KIR receptors, their ligands, and Fcgamma receptors in the response of neuroblastoma patients to Hu14.18-IL2 immunotherapy. Cancer Res. 2010 Dec 1;70(23):9554-61. doi: 10.1158/0008-5472.CAN-10-2211. Epub 2010 Oct 8.'}, {'pmid': '20921469', 'type': 'RESULT', 'citation': "Shusterman S, London WB, Gillies SD, Hank JA, Voss SD, Seeger RC, Reynolds CP, Kimball J, Albertini MR, Wagner B, Gan J, Eickhoff J, DeSantes KB, Cohn SL, Hecht T, Gadbaw B, Reisfeld RA, Maris JM, Sondel PM. Antitumor activity of hu14.18-IL2 in patients with relapsed/refractory neuroblastoma: a Children's Oncology Group (COG) phase II study. J Clin Oncol. 2010 Nov 20;28(33):4969-75. doi: 10.1200/JCO.2009.27.8861. Epub 2010 Oct 4."}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Biological therapies such as hu14.18-interleukin-2 fusion protein work in different ways to stimulate the immune system and stop tumor cells from growing.\n\nPURPOSE: This phase II trial is studying how well hu14.18-interleukin-2 fusion protein works in treating young patients with recurrent or refractory neuroblastoma.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the response rate in children with recurrent or refractory neuroblastoma treated with hu14.18-interleukin-2 (hu14.18-IL2) fusion protein.\n* Determine the adverse events of this drug in these patients.\n* Determine the immunologic activation in patients treated with this drug.\n* Determine the induction of anti-hu14.18-IL2 antibody in patients treated with this drug.\n* Correlate antitumor response with measurements of toxicity, immune activation, and anti-hu14.18-IL2 antibody activity in patients treated with this drug.\n\nOUTLINE: This is a multicenter study. Patients are stratified according to measurable/evaluable disease (measurable by standard radiographic criteria vs evaluable by MIBG (meta-iodobenzylguanidine) scanning and/or bone marrow histology vs disease identified and quantified by bone marrow immunohistochemistry).\n\nFor standard radiographic criteria this study will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute. Complete Response (CR) - Disappearance of all target lesions. No evidence of tumor at any site (chest, abdomen, liver, bone, bone marrow, nodes, etc). Very Good Partial Response (VGPR) - Greater than 90% decrease of the disease measurement for CT/MRI target lesions, taking as reference the disease measurement done to confirm measurable disease in target lesions at study entry; all pre-existing bone lesions with CR by MIBG; MIBG scan can be SD or CR in soft tissue lesions corresponding to lesions on CT/MRI. Partial Response (PR) - At least a 30% decrease in the disease measurement for CT/MRI target lesions, taking as reference the disease measurement done to confirm measurable disease in target lesions at study entry. Progressive Disease (PD) - Any one of the following: a) At least a 20% increase in the disease measurement for CT/MRI target lesions, taking as reference the smallest disease measurement recorded since the start of treatment. b) Appearance of one or more new lesions or new sites of tumor. c) PD as defined above for either bone marrow or MIBG lesions.\n\nStable disease (SD) - The patient will be classified as stable disease for overall response if there is stable disease by either CT/MRI lesion, bone marrow, or MIBG criteria. No new lesions; no new sites of disease.\n\nPatients will be enrolled in 3 strata, and evaluated for antitumor response following 2 monthly courses (treatment on Days 1-3, followed by 25 days of observation,). Patients with progressive disease will be taken off protocol therapy. Patients with stabilization or regression of disease will be eligible to receive 2 more monthly courses of treatment. Additional treatment following course 4 will be allowed for patients showing a continued clinical response, up to a maximum of 10 courses of treatment.\n\nPatients are followed for survival.\n\nPROJECTED ACCRUAL: A total of 40-60 patients (20 for strata 1 and 2 and 0-20 for stratum 3) will be accrued for this study within 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed neuroblastoma\n* Relapsed or refractory to conventional therapy\n* Measurable or evaluable disease documented by 1 of the following criteria:\n\n * Clinical\n * Radiographic\n * Histologic\n * MIBG (meta-iodobenzylguanidine) scanning\n * Immunocytochemistry\n* No symptomatic pleural effusions or ascites requiring constant or intermittent drainage\n* No clinical or radiological evidence of central nervous system (CNS) disease\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 21 and under\n\nPerformance status\n\n* Karnofsky 50-100% (\\> 16 years of age)\n* Lansky 50-100% (≤ 16 years of age)\n\nLife expectancy\n\n* At least 8 weeks\n\nHematopoietic\n\n* Absolute neutrophil count \\> 1,000/mm\\^3\n* Platelet count ≥ 75,000/mm\\^3\\*\n\n * Must not be refractory to platelet transfusions\n* Hemoglobin ≥ 9.0 g/dL\\* NOTE: \\*Transfusion allowed if patient is known to have a history of bone marrow involvement with tumor\n\nHepatic\n\n* Alanine transaminase (ALT) \\< 2.5 times upper limit of normal (ULN)\n* Bilirubin ≤ 1.5 times ULN\n* Hepatitis B surface antigen negative\n\nRenal\n\n* Creatinine adjusted according to age as follows:\n\n * No greater than 0.4 mg/dL (≤ 5 months)\n * No greater than 0.5 mg/dL (6 months -11 months)\n * No greater than 0.6 mg/dL (1 year-23 months)\n * No greater than 0.8 mg/dL (2 years-5 years)\n * No greater than 1.0 mg/dL (6 years-9 years)\n * No greater than 1.2 mg/dL (10 years-12 years)\n * No greater than 1.4 mg/dL (13 years and over \\[female\\])\n * No greater than 1.5 mg/dL (13 years to 15 years \\[male\\])\n * No greater than 1.7 mg/dL (16 years and over \\[male\\]) OR\n* Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min\n\nCardiovascular\n\n* Shortening fraction ≥ 27% by echocardiogram OR\n* Ejection fraction ≥ 50% by Multi Gated Acquisition Scan (MUGA)\n* No symptomatic congestive heart failure\n* No uncontrolled cardiac rhythm disturbance\n\nPulmonary\n\n* Pulse oximetry \\> 94% on room air\n* Forced vital capacity (FVC) \\> 80%\n* Forced expiratory volume (FEV\\_1) \\> 80%\n* No abnormal respiratory function\n* No dyspnea at rest\n* No exercise intolerance\n* No prior history of ventilator support related to lung injury (e.g., pneumonia, hemorrhagic pneumonitis, or capillary leakage)\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* HIV negative\n* No active uncontrolled infection\n* No active uncontrolled peptic ulcer\n* No objective peripheral neuropathy ≥ grade 2\n* No significant psychiatric disabilities\n* No seizure disorders requiring antiseizure medications\n* No other concurrent significant illness\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Recovered from prior immunotherapy\n* Prior in vivo monoclonal antibodies for biologic therapy or tumor imaging allowed provided there is documented absence of detectable antibody to hu14.18 by serology\n* More than 28 days since prior autologous stem cell transplantation\n\n * Prior autologous marrow or stem cell infusion using monoclonal antibody-purged specimens allowed\n* More than 1 week since prior growth factors\n* At least 7 days since prior nonmyelosuppressive biologic agents\n* No prior allogeneic bone marrow or stem cell transplantation\n* No concurrent immunomodulating agents\n* No concurrent growth factors\n\nChemotherapy\n\n* More than 3 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered\n* No concurrent anticancer chemotherapy\n\nEndocrine therapy\n\n* No concurrent corticosteroids except 100 mg or less of hydrocortisone (or equivalent) as premedication for blood transfusion or treatment for transfusion reaction\n\n * No other use of systemic steroids\n\nRadiotherapy\n\n* Recovered from prior radiotherapy\n* At least 2 weeks since prior local palliative radiotherapy (small port)\n* At least 6 months since prior craniospinal radiotherapy\n* At least 6 months since prior total body irradiation\n* At least 6 months since prior radiotherapy to ≥ 50% of the pelvis\n* At least 6 weeks since other prior substantial bone marrow radiotherapy\n* Concurrent radiotherapy to localized painful lesions allowed provided at least 1 measurable or evaluable lesion is not irradiated\n\nSurgery\n\n* More than 2 weeks since prior major surgery (e.g., laparotomy or thoracotomy)\n* No prior organ allografts\n\nOther\n\n* No concurrent immunosuppressive drugs\n* No other concurrent myelosuppressive antineoplastic drugs'}, 'identificationModule': {'nctId': 'NCT00082758', 'briefTitle': 'hu14.18-Interleukin-2 Fusion Protein in Treating Young Patients With Recurrent or Refractory Neuroblastoma', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'A Phase II Study Of hu14.18-IL2 In Children With Recurrent Or Refractory Neuroblastoma', 'orgStudyIdInfo': {'id': 'ANBL0322'}, 'secondaryIdInfos': [{'id': 'CDR0000360723', 'type': 'OTHER', 'domain': 'Clinical Trials.gov'}, {'id': 'COG-ANBL0322', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'NCI-2012-02583', 'type': 'OTHER', 'domain': 'NCI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Disease Measurable by Standard Criteria(hu14.18-interleukin-2)', 'description': 'Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute.\n\nhu14.18-Interleukin-2 fusion protein : Given IV', 'interventionNames': ['Biological: hu14.18-Interleukin-2 fusion protein']}, {'type': 'EXPERIMENTAL', 'label': 'Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2)', 'description': 'Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by meta-iodobenzylguanidine (MIBG) scanning and/or by bone marrow (BM) histology.\n\nhu14.18-Interleukin-2 fusion protein : Given IV', 'interventionNames': ['Biological: hu14.18-Interleukin-2 fusion protein']}, {'type': 'EXPERIMENTAL', 'label': 'Disease Identified by BM Immunohistochemistry Only', 'description': 'Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by meta-iodobenzylguanidine (MIBG) scanning or bone marrow (BM) histology, however, disease is identified and quantified by BM immunohistochemistry (\\>5 neuroblastoma cells per 1,000,000 nucleated marrow cells).\n\nhu14.18-Interleukin-2 fusion protein : Given IV', 'interventionNames': ['Biological: hu14.18-Interleukin-2 fusion protein']}], 'interventions': [{'name': 'hu14.18-Interleukin-2 fusion protein', 'type': 'BIOLOGICAL', 'otherNames': ['IMMUNOCYTOKINE HU14.18-IL2 FUSION PROTEIN', 'humanized anti GD2 antibody fused with human IL-2', 'BB-IND-9798'], 'description': 'Given IV', 'armGroupLabels': ['Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2)', 'Disease Identified by BM Immunohistochemistry Only', 'Disease Measurable by Standard Criteria(hu14.18-interleukin-2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Cancer Research Center at University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Childrens Hospital Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '93638-8762', 'city': 'Madera', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Central California", 'geoPoint': {'lat': 36.96134, 'lon': -120.06072}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital of Orange County", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Cancer Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Comprehensive Cancer Center - Stanford', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80218-1088', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Cancer Center", 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '20010-2970', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32610-0232', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Shands Cancer Center', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32504', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Sacred Heart Cancer Center at Sacred Heart Hospital', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': "St. Joseph's Cancer Institute at St. Joseph's Hospital", 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': "Kaplan Cancer Center at St. Mary's Medical Center", 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30912-3730', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'MBCCOP - Medical College of Georgia Cancer Center', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '60614', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Children's Memorial Hospital - Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637-1470', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Cancer Research Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '62794-9620', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Southern Illinois University School of Medicine', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '46202-5289', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Melvin and Bren Simon Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40536-0293', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Markey Cancer Center at University of Kentucky Chandler Medical Center', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '40232', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': "Kosair Children's Hospital", 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '71315-3198', 'city': 'Alexandria', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane Cancer Center Office of Clinical Research', 'geoPoint': {'lat': 31.31129, 'lon': -92.44514}}, {'zip': '04401', 'city': 'Bangor', 'state': 'Maine', 'country': 'United States', 'facility': 'CancerCare of Maine at Eastern Maine Medial Center', 'geoPoint': {'lat': 44.79884, 'lon': -68.77265}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Floating Hospital for Children at Tufts - 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