Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-04-10 @ 5:11 AM
Study NCT ID:
NCT00567567
Status:
COMPLETED
Last Update Posted:
2022-04-28
First Post:
2007-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D016190', 'term': 'Carboplatin'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'C044245', 'term': '1,2-diaminocyclohexaneplatinum II citrate'}, {'id': 'D010984', 'term': 'Platinum'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D015474', 'term': 'Isotretinoin'}, {'id': 'D008558', 'term': 'Melphalan'}, {'id': 'D036102', 'term': 'Peripheral Blood Stem Cell Transplantation'}, {'id': 'D013852', 'term': 'Thiotepa'}, {'id': 'D019772', 'term': 'Topotecan'}, {'id': 'D014750', 'term': 'Vincristine'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'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': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D012176', 'term': 'Retinoids'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D018380', 'term': 'Hematopoietic Stem Cell Transplantation'}, {'id': 'D033581', 'term': 'Stem Cell Transplantation'}, {'id': 'D017690', 'term': 'Cell Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013721', 'term': 'Triethylenephosphoramide'}, {'id': 'D001388', 'term': 'Aziridines'}, {'id': 'D001389', 'term': 'Azirines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-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': {'otherDetails': 'Must obtain prior Sponsor approval.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': "We've excluded the ineligibles from this table.", 'eventGroups': [{'id': 'EG000', 'title': 'Single HST (CEM)', 'description': 'Induction therapy + single myeloablative consolidation', 'otherNumAtRisk': 206, 'otherNumAffected': 196, 'seriousNumAtRisk': 206, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'Tandem HST (CEM), Randomly Assigned', 'description': 'Induction therapy + tandem myeloablative consolidation', 'otherNumAtRisk': 176, 'otherNumAffected': 163, 'seriousNumAtRisk': 176, 'seriousNumAffected': 15}, {'id': 'EG002', 'title': 'Not Assigned', 'description': 'Patients that either failed during Induction therapy or refused randomization', 'otherNumAtRisk': 269, 'otherNumAffected': 230, 'seriousNumAtRisk': 269, 'seriousNumAffected': 12}], 'otherEvents': [{'term': '13200-Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 35, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 37, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 42, 'numAffected': 33}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '17200-Blood and lymphatic system disorders - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '25800-Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '33300-Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 46, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 41, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 53, 'numAffected': 46}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '20000-Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '20100-Cardiac disorders - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '39000-Heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '63100-Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '72700-Right ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '27900-Ear and labyrinth disorders - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '38900-Hearing impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '11200-Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '31900-Eye disorders - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '10100-Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '10300-Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '14900-Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '22100-Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '25700-Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '26600-Duodenal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '29400-Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '31200-Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '36400-Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '36700-Gastrointestinal disorders - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '44200-Ileal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '44600-Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '46300-Intra-abdominal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '53000-Lower gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '55600-Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '57600-Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '58900-Obstruction gastric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '59700-Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '75600-Small intestinal mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '75700-Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '81900-Typhlitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '87900-Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '28200-Edema face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '33200-Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '33900-Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '37200-General disorders and administration site conditions - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '48700-Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '60600-Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '35500-Gallbladder pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '40600-Hepatobiliary disorders - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '66500-Portal hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '12000-Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '13100-Anaphylaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '44700-Immune system disorders - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '13400-Anorectal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '16800-Bladder infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '20500-Catheter related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '25600-Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '29500-Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '38300-Gum infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '44800-Infections and infestations - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 48, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 45, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 68, 'numAffected': 39}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '53100-Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '60100-Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '62500-Pelvic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '66100-Pleural infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '73700-Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '75200-Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '76000-Small intestine infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '82300-Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '83100-Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '88900-Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '14500-Arterial injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'CTCv4'}, {'term': '34900-Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'CTCv4'}, {'term': '46500-Intraoperative arterial injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'CTCv4'}, {'term': '66800-Postoperative hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'CTCv4'}, {'term': '66900-Postoperative thoracic procedure complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'CTCv4'}, {'term': '80700-Tracheal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'CTCv4'}, {'term': '86400-Vascular access complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'CTCv4'}, {'term': '10900-Activated partial thromboplastin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '11600-Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '11800-Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '15000-Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '17400-Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '24100-Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '34000-Fibrinogen decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '37500-GGT increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '45800-INR increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '52600-Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '53700-Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 16, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 16, 'numAffected': 12}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '58300-Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 254, 'numAffected': 185}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 192, 'numAffected': 148}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 287, 'numAffected': 217}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '65800-Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 237, 'numAffected': 146}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 177, 'numAffected': 124}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 269, 'numAffected': 175}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '73900-Serum amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '83600-Urine output decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '88300-Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '88500-White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 48, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 42, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 52, 'numAffected': 36}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '10700-Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '11900-Alkalosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '13500-Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 21, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 16, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '24700-Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '41300-Hypercalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '41400-Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '41600-Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '41700-Hypermagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '42500-Hyperuricemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '42600-Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '42700-Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '42900-Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '43100-Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 48, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 43, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 26, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '43200-Hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '43300-Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '43500-Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '48500-Iron overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '14700-Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '16200-Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '37300-Generalized muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '55900-Muscle weakness lower limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '60700-Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '58000-Neoplasms benign malignant and unspecified (incl cysts and polyps) - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'CTCv4'}, {'term': '15300-Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '22000-Cognitive disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '25300-Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '31800-Extrapyramidal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '38800-Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '58100-Nervous system disorders - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '63900-Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '64100-Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '73600-Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '11400-Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '23000-Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '11100-Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '39300-Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '62600-Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '11300-Adult respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '14100-Apnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '15100-Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '15400-Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '19200-Bronchopulmonary hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '27800-Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '29700-Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '43900-Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '64900-Pharyngeal mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '65300-Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '65900-Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '66300-Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '68700-Pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '69000-Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '71500-Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '71600-Respiratory thoracic and mediastinal disorders - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '78100-Stridor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '68400-Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '69700-Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '75300-Skin ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '84100-Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '42100-Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '43600-Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '53300-Lymph leakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '79600-Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '86500-Vascular disorders - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '87500-Visceral arterial ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'CTCv4'}], 'seriousEvents': [{'term': '13200-Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '17200-Blood and lymphatic system disorders - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '25800-Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '33300-Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '39600-Hemolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '39700-Hemolytic uremic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '20000-Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '51700-Left ventricular systolic dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '63100-Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '72700-Right ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '31900-Eye disorders - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '14900-Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '35900-Gastric hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '36700-Gastrointestinal disorders - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '36900-Gastrointestinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '53000-Lower gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '55600-Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '70100-Rectal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '75700-Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '81900-Typhlitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '82200-Upper gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '24600-Death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '37200-General disorders and administration site conditions - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '55700-Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '40000-Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '40600-Hepatobiliary disorders - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '66500-Portal hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '66600-Portal vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '20500-Catheter related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '44800-Infections and infestations - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '73700-Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': '13800-Aortic injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'CTCv4'}, {'term': '45400-Injury to inferior vena cava', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'CTCv4'}, {'term': '47700-Intraoperative renal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'CTCv4'}, {'term': '10900-Activated partial thromboplastin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '11600-Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '15000-Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '17400-Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '24100-Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '37500-GGT increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '45800-INR increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '58300-Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '65800-Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '88200-Weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '88500-White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': '41300-Hypercalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '41800-Hypernatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '42600-Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '42700-Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '43100-Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '43300-Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '43500-Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '54900-Metabolism and nutrition disorders - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '81700-Tumor lysis syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '58000-Neoplasms benign malignant and unspecified (incl cysts and polyps) - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'CTCv4'}, {'term': '81200-Treatment related secondary malignancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'CTCv4'}, {'term': '25300-Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '29000-Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '56600-Myelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '58100-Nervous system disorders - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '11100-Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '71000-Renal and urinary disorders - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '19200-Bronchopulmonary hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '27800-Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '29700-Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '43900-Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '65900-Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '66300-Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '69000-Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '71500-Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '71600-Respiratory thoracic and mediastinal disorders - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '75300-Skin ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '79000-Surgical and medical procedures - Other specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'sourceVocabulary': 'CTCv4'}, {'term': '42100-Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'CTCv4'}, {'term': '43600-Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 269, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'CTCv4'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Event-free Survival Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Single HST (CEM)', 'description': 'Induction therapy + single myeloablative consolidation'}, {'id': 'OG001', 'title': 'Tandem HST (CEM), Randomly Assigned', 'description': 'Induction therapy + tandem myeloablative consolidation'}], 'classes': [{'categories': [{'measurements': [{'value': '48.8', 'groupId': 'OG000', 'lowerLimit': '41.1', 'upperLimit': '56.5'}, {'value': '61.8', 'groupId': 'OG001', 'lowerLimit': '53.8', 'upperLimit': '69.8'}]}]}], 'analyses': [{'pValue': '0.0082', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Log Rank Test Statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.9883', 'groupDescription': 'The event-free survival distributions of patients randomized to Regimen A - Single HST (CEM) and randomized to Regimen B - Tandem HST (CEM) were compared using the log-rank test.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Three years, from time of randomization', 'description': 'Comparison of EFS curves, starting from the time of randomization, by treatment group (single CEM vs. tandem CEM)', 'unitOfMeasure': 'percent probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible, randomized patients.'}, {'type': 'PRIMARY', 'title': 'Response After Induction Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '233', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Single HST (CEM)', 'description': 'Induction therapy + single myeloablative consolidation'}, {'id': 'OG001', 'title': 'Tandem HST (CEM), Randomly Assigned', 'description': 'Induction therapy + tandem myeloablative consolidation'}, {'id': 'OG002', 'title': 'Not Assigned', 'description': 'Patients that either failed during Induction therapy or refused randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '0.54', 'groupId': 'OG000', 'lowerLimit': '0.47', 'upperLimit': '0.61'}, {'value': '0.48', 'groupId': 'OG001', 'lowerLimit': '0.41', 'upperLimit': '0.56'}, {'value': '0.35', 'groupId': 'OG002', 'lowerLimit': '0.29', 'upperLimit': '0.41'}]}]}], 'analyses': [{'pValue': '0.0034', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Chi-squared test statistic', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.5751', 'groupDescription': 'Chi-square test of proportions in all patients to compare the proportion of responders (complete response \\[CR\\]+ very good partial response \\[VGPR\\]) at the end of induction therapy in this study to an analogous cohort of responders in A3973.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Study enrollment to the end of induction therapy', 'description': 'Per the International Response Criteria: measurable tumor defined as product of longest x widest perpendicular diameter. Elevated catecholamine levels, tumor cell invasion of bone marrow also considered measurable tumor. Complete Response (CR)-no evidence of primary tumor or metastases. Very Good Partial Response (VGPR)-\\>90% reduction of primary tumor; no metastases; no new bone lesions, all pre-existing lesions improved. Partial Response (PR)-50-90% reduction of primary tumor; \\>50% reduction in measurable sites of metastases; 0-1 bone marrow samples with tumor; number of positive bone sites decreased by \\>50%. Mixed Response (MR)-\\>50% reduction of any measurable lesion (primary or metastases) with \\<50% reduction in other sites; no new lesions; \\<25% increase in any existing lesion. No Response (NR)-no new lesions; \\<50% reduction but \\<25% increase in any existing legions. Progressive Disease (PD)-any new/increased measurable lesion by \\>25%; previous negative marrow positive.', 'unitOfMeasure': 'Proportion participants that responded', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients evaluated for response at the end of induction therapy.'}, {'type': 'PRIMARY', 'title': 'Incidence Rate of Local Recurrence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single HST (CEM)', 'description': 'Induction therapy + single myeloablative consolidation'}], 'classes': [{'categories': [{'measurements': [{'value': '15.7', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '23.9'}]}]}], 'analyses': [{'pValue': '0.5615', 'groupIds': ['OG000'], 'paramType': "Gray's test statistic", 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.33709', 'groupDescription': "The cumulative incidence rates of local recurrence between patients from ANBL0532 randomized or assigned to receive single CEM transplant and boost radiation and A3973 patients who were transplanted and received boost radiation were compared using Gray's test.", 'statisticalMethod': "Gray's test for competing risks", 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 years', 'description': 'Cumulative incidence rate of local recurrence comparison between ANBL0532 patients randomized or assigned to receive single CEM transplant and boost radiation versus the historical A3973 patients who were transplanted and received boost radiation.', 'unitOfMeasure': 'Percentage 3-year cumulative incidence', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients randomized or assigned to the single HST (CEM) treatment arm who also received boost radiation.'}, {'type': 'SECONDARY', 'title': 'Duration of Greater Than or Equal to Grade 3 Neutropenia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Single HST (CEM)', 'description': 'Induction therapy + single myeloablative consolidation'}, {'id': 'OG001', 'title': 'Tandem HST (CEM), Randomly Assigned', 'description': 'Induction therapy + tandem myeloablative consolidation'}, {'id': 'OG002', 'title': 'Not Assigned', 'description': 'Patients that either failed during Induction therapy or refused randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '20'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '39'}, {'value': '7', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '35'}]}]}], 'analyses': [{'pValue': '0.0939', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0557', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': "Through completion of a participant's first cycle during induction, including treatment delays, assessed up to 39 days", 'description': 'A logistic regression model will be used to test the ability of the number of days of neutropenia to predict the presence of a polymorphism.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients with available polymorphism and neutropenia toxicity data.'}, {'type': 'SECONDARY', 'title': 'Duration of Greater Than or Equal to Grade 3 Thrombocytopenia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Single HST (CEM)', 'description': 'Induction therapy + single myeloablative consolidation'}, {'id': 'OG001', 'title': 'Tandem HST (CEM), Randomly Assigned', 'description': 'Induction therapy + tandem myeloablative consolidation'}, {'id': 'OG002', 'title': 'Not Assigned', 'description': 'Patients that either failed during Induction therapy or refused randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '30'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '46'}, {'value': '4', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '44'}]}]}], 'analyses': [{'pValue': '0.3277', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0543', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': "Through completion of a participant's first cycle during induction, including treatment delays, assessed up to 46 days", 'description': 'A logistic regression model will be used to test the ability of the number of days of thrombocytopenia to predict the presence of a polymorphism.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients with available polymorphism and thrombocytopenia toxicity data.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With a Polymorphism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Single HST (CEM)', 'description': 'Induction therapy + single myeloablative consolidation'}, {'id': 'OG001', 'title': 'Tandem HST (CEM), Randomly Assigned', 'description': 'Induction therapy + tandem myeloablative consolidation'}, {'id': 'OG002', 'title': 'Not Assigned', 'description': 'Patients that either failed during Induction therapy or refused randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '0.96', 'groupId': 'OG000'}, {'value': '0.96', 'groupId': 'OG001'}, {'value': '0.97', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.7598', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4328', 'ciLowerLimit': '0.4105', 'ciUpperLimit': '5.001', 'groupDescription': 'Null Hypothesis: The response rate after two cycles of induction therapy and the presence of a polymorphism are independent in the study population', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': "Fisher's exact test was used instead of chi-square test due to small expected cell counts."}], 'paramType': 'NUMBER', 'timeFrame': "Through completion of a participant's first two cycles during induction, including treatment delays, assessed up to 69 days", 'description': 'A chi-square test will be used to test whether the response rate after two cycles of induction therapy and the presence of a polymorphism are independent in the study population.', 'unitOfMeasure': 'Proportion of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients with available polymorphism data and response data after two cycles of induction therapy. Measure value is the proportion of patients with a polymorphism.'}, {'type': 'SECONDARY', 'title': 'Surgical Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '270', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Single HST (CEM)', 'description': 'Induction therapy + single myeloablative consolidation'}, {'id': 'OG001', 'title': 'Tandem HST (CEM), Randomly Assigned', 'description': 'Induction therapy + tandem myeloablative consolidation'}, {'id': 'OG002', 'title': 'Not Assigned', 'description': 'Patients that either failed during Induction therapy or refused randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '83.98', 'groupId': 'OG000'}, {'value': '84.09', 'groupId': 'OG001'}, {'value': '58.89', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 years', 'description': 'Percentage of patients who achieved a surgical complete resection', 'unitOfMeasure': 'Percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients enrolled on ANBL0532.'}, {'type': 'SECONDARY', 'title': 'Type of Surgical or Radiotherapy Complication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '270', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Single HST (CEM)', 'description': 'Induction therapy + single myeloablative consolidation'}, {'id': 'OG001', 'title': 'Tandem HST (CEM), Randomly Assigned', 'description': 'Induction therapy + tandem myeloablative consolidation'}, {'id': 'OG002', 'title': 'Not Assigned', 'description': 'Patients that either failed during Induction therapy or refused randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '13.11', 'groupId': 'OG000'}, {'value': '12.50', 'groupId': 'OG001'}, {'value': '11.85', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 years', 'description': 'The Percentage of patients who experienced surgical or radiotherapy complications will be calculated. The complications are: bowel obstruction, chylous leaf, renal injury/atrophy/loss and diarrhea.', 'unitOfMeasure': 'Percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients enrolled on ANBL0532.'}, {'type': 'SECONDARY', 'title': 'Intraspinal Extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '270', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Single HST (CEM)', 'description': 'Induction therapy + single myeloablative consolidation'}, {'id': 'OG001', 'title': 'Tandem HST (CEM), Randomly Assigned', 'description': 'Induction therapy + tandem myeloablative consolidation'}, {'id': 'OG002', 'title': 'Not Assigned', 'description': 'Patients that either failed during Induction therapy or refused randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '8.25', 'groupId': 'OG000'}, {'value': '9.66', 'groupId': 'OG001'}, {'value': '7.78', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years', 'description': 'Percentage of patients with primary tumors with intraspinal extension.', 'unitOfMeasure': 'Percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients enrolled on ANBL0532.'}, {'type': 'SECONDARY', 'title': 'Peak Serum Concentration of Isotretinoin in Patients Enrolled on Either A3973, ANBL0032, ANBL0931, ANBL0532 and Future High Risk Studies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Single HST (CEM)', 'description': 'Induction therapy + single myeloablative consolidation'}, {'id': 'OG001', 'title': 'Tandem HST (CEM), Randomly Assigned', 'description': 'Induction therapy + tandem myeloablative consolidation'}, {'id': 'OG002', 'title': 'Not Assigned', 'description': 'Patients that either failed during Induction therapy or refused randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9.22'}, {'value': '1.36', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '12.93'}, {'value': '1.26', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '11.78'}]}]}], 'analyses': [{'pValue': '0.6853', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.015', 'groupDescription': 'The relationship between the peak serum isotretinoin concentration level with event-free survival was explored with a Cox proportional hazards model. Eligible patients treated with isotretinoin on A3973, ANBL0032, ANBL0532, or ANBL0931 with peak serum concentration level data were included in the analysis.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 of each course', 'description': 'Median peak serum concentration level of isotretinoin for patients enrolled on ANBL0532', 'unitOfMeasure': 'Micromolar', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients evaluated for peak serum concentration level of isotretinoin.'}, {'type': 'SECONDARY', 'title': 'Pharmacogenetic Variants in Patients Enrolled on Either A3973, ANBL0032, ANBL0931, ANBL0532 and Future High Risk Studies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'All eligible and evaluable patients enrolled on ANBL0532'}], 'timeFrame': 'At baseline', 'description': "To determine if pharmacogenomic variations are predictive of EFS, a logrank test comparison of patients with vs without a given polymorphism will be made. A Fisher's exact test will test for association of the presence of a polymorphism with the occurrence of systemic toxicity (CTC grade 3 or 4 skin, hypercalcemia, or hepatic toxicity). These tests will be performed for UGT1A1, UGT2B7, CYP2C8 and CYP3A7 alleles.", 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected to assess this study aim.'}, {'type': 'SECONDARY', 'title': 'Topotecan Systemic Clearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Single HST (CEM)', 'description': 'Induction therapy + single myeloablative consolidation'}, {'id': 'OG001', 'title': 'Tandem HST (CEM), Randomly Assigned', 'description': 'Induction therapy + tandem myeloablative consolidation'}, {'id': 'OG002', 'title': 'Not Assigned', 'description': 'Patients that either failed during Induction therapy or refused randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '28.1', 'groupId': 'OG000', 'lowerLimit': '14.9', 'upperLimit': '49.4'}, {'value': '28.1', 'groupId': 'OG001', 'lowerLimit': '11.6', 'upperLimit': '42.7'}, {'value': '28.5', 'groupId': 'OG002', 'lowerLimit': '16.3', 'upperLimit': '54.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 of courses 1-2', 'description': 'Median topotecan systemic clearance for courses 1 and 2.', 'unitOfMeasure': 'L/h/m2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Eligible patients evaluated for topotecan systemic clearance.'}, {'type': 'SECONDARY', 'title': 'Presence and Function of T Cells Capable of Recognizing Neuroblastoma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Single HST (CEM)', 'description': 'Induction therapy + single myeloablative consolidation'}, {'id': 'OG001', 'title': 'Tandem HST (CEM), Randomly Assigned', 'description': 'Induction therapy + tandem myeloablative consolidation'}, {'id': 'OG002', 'title': 'Not Assigned', 'description': 'Patients that either failed during Induction therapy or refused randomization'}], 'timeFrame': 'Up to 6 months (end of therapy)', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected to assess this study aim.'}, {'type': 'SECONDARY', 'title': 'Enumeration of Peripheral Blood Cluster of Differentiation (CD)3, CD4, and CD8 Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Single HST (CEM)', 'description': 'Induction therapy + single myeloablative consolidation'}, {'id': 'OG001', 'title': 'Tandem HST (CEM), Randomly Assigned', 'description': 'Induction therapy + tandem myeloablative consolidation'}], 'classes': [{'title': 'CD3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '200', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '1549'}, {'value': '255.5', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '2987'}]}]}, {'title': 'CD4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '626'}, {'value': '81', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '1186'}]}]}, {'title': 'CD8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '1170'}, {'value': '151', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '2529'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 6 months after completion of assigned myeloablation therapy', 'description': 'A descriptive comparison of the median number of T-cells (CD3, CD4, CD8) between treatment arms (single vs. tandem myeloablative regimens) will be performed.', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients that had CD3, CD4 and CD8T-cell count evaluated at the end of reporting period 3.'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With Neuroblastoma Detected in Bone Marrow and Peripheral Blood Using RT-PCR Technique', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Single HST (CEM)', 'description': 'Induction therapy + single myeloablative consolidation'}, {'id': 'OG001', 'title': 'Tandem HST (CEM), Randomly Assigned', 'description': 'Induction therapy + tandem myeloablative consolidation'}, {'id': 'OG002', 'title': 'All Eligible Patients', 'description': 'All Eligible Patients'}], 'timeFrame': 'Baseline', 'description': 'Will be calculated overall and by treatment arm.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected to assess this study aim.'}, {'type': 'SECONDARY', 'title': 'EFS Pts Non-randomly Assigned to Single CEM (12-18 Mths, Stg. 4, MYCN Nonamplified Tumor/Unfavorable or Indeterminant Histopathology/Diploid DNA Content & Pts>547 Days, Stg.3, MYCN Nonamplified Tumor AND Unfavorable or Indeterminant Histopathology).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single HST (CEM)', 'description': 'Induction therapy + single myeloablative consolidation'}], 'classes': [{'categories': [{'measurements': [{'value': '73.1', 'groupId': 'OG000', 'lowerLimit': '55.1', 'upperLimit': '91.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 years', 'description': 'Kaplan-Meier curves of EFS will be plotted, and the proportion of responders to induction therapy will be tabulated.', 'unitOfMeasure': 'percent probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients non-randomly assigned to single CEM'}, {'type': 'SECONDARY', 'title': 'OS in Patients 12-18 Months, Stage 4, MYCN Nonamplified Tumor/Unfavorable Histopathology/Diploid DNA Content/Indeterminant Histology/Ploidy and Patients > 547 Days, Stage 3, MYCN Nonamplified Tumor AND Unfavorable Histopathology/Indeterminant Histology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single HST (CEM)', 'description': 'Induction therapy + single myeloablative consolidation'}], 'classes': [{'categories': [{'measurements': [{'value': '81.0', 'groupId': 'OG000', 'lowerLimit': '65.1', 'upperLimit': '96.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 years', 'description': 'Kaplan-Meier curves of OS will be plotted, and the proportion of responders to induction therapy will be tabulated.', 'unitOfMeasure': 'percent probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single HST (CEM)', 'description': 'Induction therapy + single myeloablative consolidation'}, {'id': 'FG001', 'title': 'Tandem HST (CEM), Randomly Assigned', 'description': 'Induction therapy + tandem myeloablative consolidation'}, {'id': 'FG002', 'title': 'Not Assigned', 'description': 'Patients that either failed during Induction therapy or refused randomization'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '210'}, {'groupId': 'FG001', 'numSubjects': '176'}, {'groupId': 'FG002', 'numSubjects': '279'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '42'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '134'}, {'groupId': 'FG002', 'numSubjects': '278'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '48'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '84'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Refusal by patient/parent/guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '122'}]}, {'type': 'Enrolled another COG therapeutic study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '80'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Unable adequate stem cell for transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '210', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}, {'value': '665', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Single HST (CEM)', 'description': 'Induction therapy + single myeloablative consolidation'}, {'id': 'BG001', 'title': 'Tandem HST (CEM), Randomly Assigned', 'description': 'Induction therapy + tandem myeloablative consolidation'}, {'id': 'BG002', 'title': 'Not Assigned', 'description': 'Patients that either failed during Induction therapy or refused randomization'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '208', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '277', 'groupId': 'BG002'}, {'value': '661', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'spread': '2.9', 'groupId': 'BG000'}, {'value': '2.9', 'spread': '2.4', 'groupId': 'BG001'}, {'value': '3.4', 'spread': '2.8', 'groupId': 'BG002'}, {'value': '3.2', 'spread': '2.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '291', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}, {'value': '374', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '181', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}, {'value': '559', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '157', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '203', 'groupId': 'BG002'}, {'value': '492', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'New Zealand', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '243', 'groupId': 'BG002'}, {'value': '565', 'groupId': 'BG003'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2011-08-16', 'size': 1330752, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-01-21T13:50', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 665}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-01', 'studyFirstSubmitDate': '2007-12-04', 'resultsFirstSubmitDate': '2017-01-20', 'studyFirstSubmitQcDate': '2007-12-04', 'lastUpdatePostDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-22', 'studyFirstPostDateStruct': {'date': '2007-12-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event-free Survival Rate', 'timeFrame': 'Three years, from time of randomization', 'description': 'Comparison of EFS curves, starting from the time of randomization, by treatment group (single CEM vs. tandem CEM)'}, {'measure': 'Response After Induction Therapy', 'timeFrame': 'Study enrollment to the end of induction therapy', 'description': 'Per the International Response Criteria: measurable tumor defined as product of longest x widest perpendicular diameter. Elevated catecholamine levels, tumor cell invasion of bone marrow also considered measurable tumor. Complete Response (CR)-no evidence of primary tumor or metastases. Very Good Partial Response (VGPR)-\\>90% reduction of primary tumor; no metastases; no new bone lesions, all pre-existing lesions improved. Partial Response (PR)-50-90% reduction of primary tumor; \\>50% reduction in measurable sites of metastases; 0-1 bone marrow samples with tumor; number of positive bone sites decreased by \\>50%. Mixed Response (MR)-\\>50% reduction of any measurable lesion (primary or metastases) with \\<50% reduction in other sites; no new lesions; \\<25% increase in any existing lesion. No Response (NR)-no new lesions; \\<50% reduction but \\<25% increase in any existing legions. Progressive Disease (PD)-any new/increased measurable lesion by \\>25%; previous negative marrow positive.'}, {'measure': 'Incidence Rate of Local Recurrence', 'timeFrame': 'Up to 3 years', 'description': 'Cumulative incidence rate of local recurrence comparison between ANBL0532 patients randomized or assigned to receive single CEM transplant and boost radiation versus the historical A3973 patients who were transplanted and received boost radiation.'}], 'secondaryOutcomes': [{'measure': 'Duration of Greater Than or Equal to Grade 3 Neutropenia', 'timeFrame': "Through completion of a participant's first cycle during induction, including treatment delays, assessed up to 39 days", 'description': 'A logistic regression model will be used to test the ability of the number of days of neutropenia to predict the presence of a polymorphism.'}, {'measure': 'Duration of Greater Than or Equal to Grade 3 Thrombocytopenia', 'timeFrame': "Through completion of a participant's first cycle during induction, including treatment delays, assessed up to 46 days", 'description': 'A logistic regression model will be used to test the ability of the number of days of thrombocytopenia to predict the presence of a polymorphism.'}, {'measure': 'Proportion of Patients With a Polymorphism', 'timeFrame': "Through completion of a participant's first two cycles during induction, including treatment delays, assessed up to 69 days", 'description': 'A chi-square test will be used to test whether the response rate after two cycles of induction therapy and the presence of a polymorphism are independent in the study population.'}, {'measure': 'Surgical Response', 'timeFrame': 'Up to 3 years', 'description': 'Percentage of patients who achieved a surgical complete resection'}, {'measure': 'Type of Surgical or Radiotherapy Complication', 'timeFrame': 'Up to 3 years', 'description': 'The Percentage of patients who experienced surgical or radiotherapy complications will be calculated. The complications are: bowel obstruction, chylous leaf, renal injury/atrophy/loss and diarrhea.'}, {'measure': 'Intraspinal Extension', 'timeFrame': 'Up to 5 years', 'description': 'Percentage of patients with primary tumors with intraspinal extension.'}, {'measure': 'Peak Serum Concentration of Isotretinoin in Patients Enrolled on Either A3973, ANBL0032, ANBL0931, ANBL0532 and Future High Risk Studies', 'timeFrame': 'Day 1 of each course', 'description': 'Median peak serum concentration level of isotretinoin for patients enrolled on ANBL0532'}, {'measure': 'Pharmacogenetic Variants in Patients Enrolled on Either A3973, ANBL0032, ANBL0931, ANBL0532 and Future High Risk Studies', 'timeFrame': 'At baseline', 'description': "To determine if pharmacogenomic variations are predictive of EFS, a logrank test comparison of patients with vs without a given polymorphism will be made. A Fisher's exact test will test for association of the presence of a polymorphism with the occurrence of systemic toxicity (CTC grade 3 or 4 skin, hypercalcemia, or hepatic toxicity). These tests will be performed for UGT1A1, UGT2B7, CYP2C8 and CYP3A7 alleles."}, {'measure': 'Topotecan Systemic Clearance', 'timeFrame': 'Day 1 of courses 1-2', 'description': 'Median topotecan systemic clearance for courses 1 and 2.'}, {'measure': 'Presence and Function of T Cells Capable of Recognizing Neuroblastoma', 'timeFrame': 'Up to 6 months (end of therapy)'}, {'measure': 'Enumeration of Peripheral Blood Cluster of Differentiation (CD)3, CD4, and CD8 Cells', 'timeFrame': 'Up to 6 months after completion of assigned myeloablation therapy', 'description': 'A descriptive comparison of the median number of T-cells (CD3, CD4, CD8) between treatment arms (single vs. tandem myeloablative regimens) will be performed.'}, {'measure': 'Proportion of Patients With Neuroblastoma Detected in Bone Marrow and Peripheral Blood Using RT-PCR Technique', 'timeFrame': 'Baseline', 'description': 'Will be calculated overall and by treatment arm.'}, {'measure': 'EFS Pts Non-randomly Assigned to Single CEM (12-18 Mths, Stg. 4, MYCN Nonamplified Tumor/Unfavorable or Indeterminant Histopathology/Diploid DNA Content & Pts>547 Days, Stg.3, MYCN Nonamplified Tumor AND Unfavorable or Indeterminant Histopathology).', 'timeFrame': 'Up to 3 years', 'description': 'Kaplan-Meier curves of EFS will be plotted, and the proportion of responders to induction therapy will be tabulated.'}, {'measure': 'OS in Patients 12-18 Months, Stage 4, MYCN Nonamplified Tumor/Unfavorable Histopathology/Diploid DNA Content/Indeterminant Histology/Ploidy and Patients > 547 Days, Stage 3, MYCN Nonamplified Tumor AND Unfavorable Histopathology/Indeterminant Histology', 'timeFrame': 'Up to 3 years', 'description': 'Kaplan-Meier curves of OS will be plotted, and the proportion of responders to induction therapy will be tabulated.'}]}, 'conditionsModule': {'conditions': ['Localized Resectable Neuroblastoma', 'Localized Unresectable Neuroblastoma', 'Recurrent Neuroblastoma', 'Regional Neuroblastoma', 'Stage 4 Neuroblastoma', 'Stage 4S Neuroblastoma']}, 'referencesModule': {'references': [{'pmid': '40036726', 'type': 'DERIVED', 'citation': "Berko ER, Naranjo A, Daniels AA, McNulty SN, Krytska K, Druley T, Zelley K, Koneru B, Chen L, Polkosnik G, Irwin MS, Bagatell R, Maris JM, Reynolds CP, DuBois SG, Park JR, Mosse YP. Frequency and Clinical Significance of Clonal and Subclonal Driver Mutations in High-Risk Neuroblastoma at Diagnosis: A Children's Oncology Group Study. J Clin Oncol. 2025 May 10;43(14):1673-1684. doi: 10.1200/JCO-24-02407. Epub 2025 Mar 4."}, {'pmid': '32530765', 'type': 'DERIVED', 'citation': "Liu KX, Naranjo A, Zhang FF, DuBois SG, Braunstein SE, Voss SD, Khanna G, London WB, Doski JJ, Geiger JD, Kreissman SG, Grupp SA, Diller LR, Park JR, Haas-Kogan DA. Prospective Evaluation of Radiation Dose Escalation in Patients With High-Risk Neuroblastoma and Gross Residual Disease After Surgery: A Report From the Children's Oncology Group ANBL0532 Study. J Clin Oncol. 2020 Aug 20;38(24):2741-2752. doi: 10.1200/JCO.19.03316. Epub 2020 Jun 12."}, {'pmid': '31454045', 'type': 'DERIVED', 'citation': 'Park JR, Kreissman SG, London WB, Naranjo A, Cohn SL, Hogarty MD, Tenney SC, Haas-Kogan D, Shaw PJ, Kraveka JM, Roberts SS, Geiger JD, Doski JJ, Voss SD, Maris JM, Grupp SA, Diller L. Effect of Tandem Autologous Stem Cell Transplant vs Single Transplant on Event-Free Survival in Patients With High-Risk Neuroblastoma: A Randomized Clinical Trial. JAMA. 2019 Aug 27;322(8):746-755. doi: 10.1001/jama.2019.11642.'}], 'seeAlsoLinks': [{'url': 'https://nctn-data-archive.nci.nih.gov/', 'label': 'Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive'}]}, 'descriptionModule': {'briefSummary': "This randomized phase III trial compares two different high-dose chemotherapy regimens followed by a stem cell transplant in treating younger patients with high-risk neuroblastoma. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments before a peripheral blood stem cell transplant helps kill any tumor cells that are in the body and helps make room in the patient?s bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. High-dose chemotherapy and radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the high- chemotherapy. It is not yet known which regimen of high-dose chemotherapy is more effective for patients with high-risk neuroblastoma undergoing a peripheral blood stem cell transplant.", 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To improve the 3-year event-free survival (EFS) rate of high-risk neuroblastoma patients through treatment with a tandem consolidation of thiotepa/cyclophosphamide followed by carboplatin/etoposide/melphalan (CEM) as compared to single CEM consolidation.\n\nII. To improve the rate of end-induction complete response and very good partial response, compared to historical controls, by use of a topotecan-containing induction regimen.\n\nIII. To improve the 3-year local control rate, compared to historical controls, by increasing the local dose of radiation to the residual primary tumor for patients with less than a gross total resection.\n\nSECONDARY OBJECTIVES:\n\nI. To evaluate the pharmacogenetic relationship of cyclophosphamide metabolizing enzymes (CYP2B6, CYP2C9, and GSTA1 genotypes) with toxicity and response following dose-intensive cyclophosphamide and topotecan induction chemotherapy.\n\nII. To determine if resection completeness is predictive of a) local control rate; or b) EFS rate in patients with high-risk neuroblastoma.\n\nIII. To prospectively describe the complications related to efforts at local control (surgery and radiation therapy) in patients with high-risk neuroblastoma.\n\nIV. To describe the neurologic outcome of patients with paraspinal primary neuroblastoma tumors.\n\nV. To determine the variability of 13-cis-retinoic-acid pharmacokinetics and relationship to pharmacogenomic parameters and determine if pharmacokinetics and/or genetic variations correlate with EFS or systemic toxicity as follows: a) To determine the variability of 13-cis-retinoic-acid pharmacokinetics and relationship to pharmacogenomic parameters. b) To determine if 13-cis-retinoic-acid pharmacokinetic levels are predictive of the EFS rate or associated with systemic toxicity following 13-cis-retinoic acid. c) To determine if pharmacogenomic variations are predictive of the EFS rate or associated with systemic toxicity following 13-cis-retinoic acid.\n\nVI. To evaluate total topotecan pharmacokinetics and correlate with patient specific data for use in an ongoing topotecan population pharmacokinetic analysis.\n\nVII. To evaluate the presence and function of T cells capable of recognizing neuroblastoma by assessing: a) if T cells recognizing the neuroblastoma antigen, survivin, circulate at diagnosis; b) if these T cells can be expanded using autologous antigen presenting cells (APCs); c) if these T cells will kill neuroblastoma cells as detected in functional assays; and d) if the presence and activity of anti-neuroblastoma immunity is decreased by stem cell transplantation.\n\nVIII. To characterize the recovery of T- cell numbers after myeloablative consolidation and hematopoietic stem cell transplant (HSCT) and assess the impact of tandem myeloablative consolidation on T- cell recovery.\n\nIX. To characterize minimal residual disease burden using reverse transcriptase-polymerase chain reaction (RT-PCR) evaluation of a panel of neuroblastoma specific transcripts in patient bone marrow and peripheral blood following induction chemotherapy and after single versus tandem myeloablative chemotherapy and to evaluate impact on EFS.\n\nX. To evaluate the EFS and overall survival (OS) rate for patients 12-18 months with Stage 4, MYCN nonamplified tumor with unfavorable histopathology or diploid DNA content or with indeterminant histology or ploidy and patients who are greater than 547 days of age with Stage 3, MYCN nonamplified tumor AND unfavorable histopathology or indeterminant histology following treatment with single myeloablative transplant.\n\nOUTLINE:\n\nINDUCTION CHEMOTHERAPY:\n\nCOURSES 1 AND 2: Patients receive cyclophosphamide IV over 30 minutes and topotecan hydrochloride IV over 30 minutes on days 1-5 and filgrastim (G-CSF) subcutaneously (SC) or IV beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses. Patients undergo peripheral blood stem cell (PBSC) mobilization and harvest after course 2.\n\nCOURSES 3 AND 5: Patients receive cisplatin IV over 1 hour on days 1-4, etoposide IV over 1 hour on days 1-3, and G-CSF SC or IV beginning on day 5 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses. Patients undergo surgical resection of soft tissue disease after course 5 (or after course 6 if medically necessary).\n\nCOURSES 4 AND 6: Patients receive cyclophosphamide IV over 6 hours on days 1-2, doxorubicin hydrochloride IV over 24 hours on days 1-3, vincristine IV on days 1-3, and G-CSF SC or IV beginning on day 5 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses.\n\nPatients are then stratified by initial stage of disease and MYCN status, biologic characteristics, and response to induction chemotherapy (complete response/very good partial response vs partial response vs mixed response/no response). Patients are randomized to 1 of 2 arms. Patients 12?18 months old (i.e., 365-547 days) with stage IV, MYCN nonamplified tumor with unfavorable histopathology or diploid DNA content or with indeterminant histology or ploidy AND patients who are 547 days of age with stage III, MYCN nonamplified tumor AND unfavorable histopathology or indeterminant histology will be nonrandomly assigned to Arm A. Patients begin consolidation chemotherapy no later than 8 weeks after the start of induction course 6.\n\nCONSOLIDATION THERAPY:\n\nARM A (single myeloablative consolidation): Patients receive melphalan IV over 15-30 minutes on days -7 to -5, etoposide IV over 24 hours and carboplatin IV over 24 hours on days -7 to -4, and G-CSF SC or IV beginning on day 0 and continuing until blood counts recover. Patients undergo autologous peripheral blood stem cell transplant (PBSCT) on day 0.\n\nARM B (tandem myeloablative consolidation): Patients receive thiotepa IV over 2 hours on days -7 to -5, cyclophosphamide IV over 1 hour on days -5 to -2, and G-CSF SC or IV beginning on day 0 and continuing until blood counts recover. Following clinical recovery from initial myeloablative therapy, patients also receive melphalan, etoposide, and carboplatin as in Arm A. Patients undergo autologous PBSCT on day 0.\n\nRADIOTHERAPY: Patients undergo external beam radiation therapy (EBRT) to primary site of disease as well as to MIBG-avid sites seen at pre-transplantation (i.e., end-induction) evaluation between 28-42 days post-transplant. Additional radiotherapy is administered to residual tumor at primary site.\n\nMAINTENANCE THERAPY: Patients are encouraged to enroll onto Children?s Oncology Group (COG)-ANBL0032 following assessment of tumor response after completion of the consolidation phase and radiotherapy. Beginning on day 60 post-transplantation patients receive oral isotretinoin twice daily on days 1-14. Treatment repeats every 28 days for up to 6 months in the absence of disease progression or unacceptable toxicity. Patients undergo blood and tissue sample collection periodically for the following analyses; correlation between peak serum concentration level and the existence of polymorphisms, event-free survival, and toxicity rates; pharmacogenomics for uridine diphosphate (UDP) glucuronosyltransferase 1 family, polypeptide A1 (UGT1A1), UGT2B7, CYP2C8 and CYP3A7 alleles; topotecan systemic clearance; survivin-specific cytotoxic T-lymphocytes (CTLs) detected using peptide/major histocompatibility complex (MHC) tetramers in human leukocyte antigen (HLA)-A2+ patients; interferon (IFN)-gamma production in enzyme-linked immunospot (ELISPOT) assays to APCs loaded with tumor ribonucleic acid (RNA), survivin RNA, or control RNA; response of APC-stimulated CTL response to neuroblastoma cells; rate of T cell recovery; and proportion of patients with neuroblastoma detected in bone marrow and peripheral blood using RT-PCR and immunohistochemistry (IHC).\n\nAfter completion of study treatment, patients are followed up periodically for 5 years and then annually for 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of neuroblastoma or ganglioneuroblastoma by histology or as evidenced by the presence of clumps of tumor cells in bone marrow and elevated catecholamine metabolites in urine meeting any of the following criteria:\n\n * Patients with newly diagnosed neuroblastoma with International Neuroblastoma Staging System (INSS) stage 4 disease are eligible with the following:\n\n * MYCN amplification (i.e., greater than four-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features\n * Age \\> 18 months (i.e., \\> 547 days) regardless of biologic features\n * Age 12-18 months (i.e., 365-547 days) with none of the following three favorable biologic features (i.e., non-amplified MYCN, favorable pathology, and deoxyribonucleic acid \\[DNA\\] index \\> 1)\n * Patients with newly diagnosed neuroblastoma with INSS stage 3 are eligible with the following:\n\n * MYCN amplification (i.e., greater than four-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features\n * Age \\> 18 months (i.e., \\> 547 days) with unfavorable pathology, regardless of MYCN status\n * Patients with newly diagnosed INSS stage 2a or 2b with MYCN amplification (i.e., greater than four-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features\n * Patients with newly diagnosed INSS stage 4s with MYCN amplification (i.e., greater than four-fold increase in MYCN signals as compared to reference signals), regardless of additional biologic features\n * Patients \\>= 365 days initially diagnosed with INSS stage 1, 2, or 4S and who progressed to a stage 4 without interval chemotherapy\n\n * Must have been enrolled on COG-ANBL00B1\n* Creatinine clearance or radioisotope glomerular filtration rate ? 70mL/min OR serum creatinine based on age/gender as follows:\n\n * 1 month to \\< 6 months: 0.4 mg/dL\n * 6 months to \\< 1 year: 0.5 mg/dL\n * 1 to \\< 2 years: 0.6 mg/dL\n * 2 to \\< 6 years: 0.8 mg/dL\n * 6 to \\< 10 years: 1 mg/dL\n * 10 to \\< 13 years: 1.2 mg/dL\n * 10 to \\< 16 years: 1.5 mg/dL (male), 1.4 mg/dL (female)\n * \\>= 16 years: 1.7 mg/dL (male), 1.4 mg/dL (female)\n* Total bilirubin ? 1.5 times upper limit of normal (ULN) for age\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\< 10 times ULN for age\n* Not pregnant or nursing\n* Negative pregnancy test\n* Shortening fraction \\>= 27% by echocardiogram (ECHO) OR left ventricular ejection fraction (LVEF) \\>= 50% by radionuclide angiogram\n* No known contraindication (e.g., size, weight or physical condition) to peripheral blood stem cell collection\n* No prior systemic therapy except for localized emergency radiation to sites of life-threatening or function-threatening disease\n* No more than one course of chemotherapy per low- or intermediate-risk neuroblastoma therapy prior to determination of MYCN amplification and histology'}, 'identificationModule': {'nctId': 'NCT00567567', 'briefTitle': 'Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'Phase III Randomized Trial of Single vs. Tandem Myeloablative Consolidation Therapy for High-Risk Neuroblastoma', 'orgStudyIdInfo': {'id': 'ANBL0532'}, 'secondaryIdInfos': [{'id': 'NCI-2009-01065', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'CDR0000576571'}, {'id': '08-524'}, {'id': 'COG-ANBL0532'}, {'id': 'ANBL0532', 'type': 'OTHER', 'domain': 'Childrens Oncology Group'}, {'id': 'ANBL0532', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA180886', 'link': 'https://reporter.nih.gov/quickSearch/U10CA180886', 'type': 'NIH'}, {'id': 'U10CA098543', 'link': 'https://reporter.nih.gov/quickSearch/U10CA098543', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Consolidation Arm A: single myeloablative consolidation', 'description': 'Patients receive melphalan IV over 15-30 minutes on days -7 to -5, etoposide IV over 24 hours and carboplatin IV over 24 hours on days -7 to -4, and G-CSF SC or IV beginning on day 0 and continuing until blood counts recover. Patients undergo autologous PBSCT on day 0.', 'interventionNames': ['Procedure: Autologous Hematopoietic Stem Cell Transplantation', 'Drug: Carboplatin', 'Drug: Cisplatin', 'Drug: Cyclophosphamide', 'Drug: Doxorubicin Hydrochloride', 'Drug: Etoposide', 'Radiation: External Beam Radiation Therapy', 'Biological: Filgrastim', 'Drug: Isotretinoin', 'Other: Laboratory Biomarker Analysis', 'Drug: Melphalan', 'Procedure: Peripheral Blood Stem Cell Transplantation', 'Other: Pharmacological Study', 'Drug: Topotecan Hydrochloride', 'Drug: Vincristine Sulfate Liposome']}, {'type': 'EXPERIMENTAL', 'label': 'Consolidation Arm B: tandem myeloablative consolidation', 'description': 'Patients receive thiotepa IV over 2 hours on days -7 to -5, cyclophosphamide IV over 1 hour on days -5 to -2, and G-CSF SC or IV beginning on day 0 and continuing until blood counts recover. Following clinical recovery from initial myeloablative therapy, patients also receive melphalan, etoposide, and carboplatin as in Arm A. Patients undergo autologous PBSCT on day 0.', 'interventionNames': ['Procedure: Autologous Hematopoietic Stem Cell Transplantation', 'Drug: Carboplatin', 'Drug: Cisplatin', 'Drug: Cyclophosphamide', 'Drug: Doxorubicin Hydrochloride', 'Drug: Etoposide', 'Radiation: External Beam Radiation Therapy', 'Biological: Filgrastim', 'Drug: Isotretinoin', 'Other: Laboratory Biomarker Analysis', 'Drug: Melphalan', 'Procedure: Peripheral Blood Stem Cell Transplantation', 'Other: Pharmacological Study', 'Drug: Thiotepa', 'Drug: Topotecan Hydrochloride', 'Drug: Vincristine Sulfate Liposome']}], 'interventions': [{'name': 'Autologous Hematopoietic Stem Cell Transplantation', 'type': 'PROCEDURE', 'otherNames': ['Autologous Hematopoietic Cell Transplantation', 'autologous stem cell transplantation'], 'description': 'Undergo autologous peripheral blood stem cell transplant', 'armGroupLabels': ['Consolidation Arm A: single myeloablative consolidation', 'Consolidation Arm B: tandem myeloablative consolidation']}, {'name': 'Carboplatin', 'type': 'DRUG', 'otherNames': ['Blastocarb', 'Carboplat', 'Carboplatin Hexal', 'Carboplatino', 'Carbosin', 'Carbosol', 'Carbotec', 'CBDCA', 'Displata', 'Ercar', 'JM-8', 'Nealorin', 'Novoplatinum', 'Paraplatin', 'Paraplatin AQ', 'Paraplatine', 'Platinwas', 'Ribocarbo'], 'description': 'Given IV', 'armGroupLabels': ['Consolidation Arm A: single myeloablative consolidation', 'Consolidation Arm B: tandem myeloablative consolidation']}, {'name': 'Cisplatin', 'type': 'DRUG', 'otherNames': ['Abiplatin', 'Blastolem', 'Briplatin', 'CDDP', 'Cis-diammine-dichloroplatinum', 'Cis-diamminedichloridoplatinum', 'Cis-diamminedichloro Platinum (II)', 'Cis-diamminedichloroplatinum', 'Cis-dichloroammine Platinum (II)', 'Cis-platinous Diamine Dichloride', 'Cis-platinum', 'Cis-platinum II', 'Cis-platinum II Diamine Dichloride', 'Cismaplat', 'Cisplatina', 'Cisplatinum', 'Cisplatyl', 'Citoplatino', 'Citosin', 'Cysplatyna', 'DDP', 'Lederplatin', 'Metaplatin', 'Neoplatin', "Peyrone's Chloride", "Peyrone's Salt", 'Placis', 'Plastistil', 'Platamine', 'Platiblastin', 'Platiblastin-S', 'Platinex', 'Platinol', 'Platinol- AQ', 'Platinol-AQ', 'Platinol-AQ VHA Plus', 'Platinoxan', 'Platinum', 'Platinum Diamminodichloride', 'Platiran', 'Platistin', 'Platosin'], 'description': 'Given IV', 'armGroupLabels': ['Consolidation Arm A: single myeloablative consolidation', 'Consolidation Arm B: tandem myeloablative consolidation']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['(-)-Cyclophosphamide', '2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate', 'Carloxan', 'Ciclofosfamida', 'Ciclofosfamide', 'Cicloxal', 'Clafen', 'Claphene', 'CP monohydrate', 'CTX', 'CYCLO-cell', 'Cycloblastin', 'Cycloblastine', 'Cyclophospham', 'Cyclophosphamid monohydrate', 'Cyclophosphamidum', 'Cyclophosphan', 'Cyclophosphane', 'Cyclophosphanum', 'Cyclostin', 'Cyclostine', 'Cytophosphan', 'Cytophosphane', 'Cytoxan', 'Fosfaseron', 'Genoxal', 'Genuxal', 'Ledoxina', 'Mitoxan', 'Neosar', 'Revimmune', 'Syklofosfamid', 'WR- 138719'], 'description': 'Given IV', 'armGroupLabels': ['Consolidation Arm A: single myeloablative consolidation', 'Consolidation Arm B: tandem myeloablative consolidation']}, {'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', 'Doxorubin', 'Farmiblastina', 'FI 106', 'FI-106', 'hydroxydaunorubicin', 'Rubex'], 'description': 'Given IV', 'armGroupLabels': ['Consolidation Arm A: single myeloablative consolidation', 'Consolidation Arm B: tandem myeloablative consolidation']}, {'name': 'Etoposide', 'type': 'DRUG', 'otherNames': ['Demethyl Epipodophyllotoxin Ethylidine Glucoside', 'EPEG', 'Lastet', 'Toposar', 'Vepesid', 'VP 16-213', 'VP-16', 'VP-16-213'], 'description': 'Given IV', 'armGroupLabels': ['Consolidation Arm A: single myeloablative consolidation', 'Consolidation Arm B: tandem myeloablative consolidation']}, {'name': 'External Beam Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['Definitive Radiation Therapy', 'EBRT', 'External Beam Radiotherapy', 'External Beam RT', 'external radiation', 'External Radiation Therapy', 'external-beam radiation'], 'description': 'Undergo EBRT', 'armGroupLabels': ['Consolidation Arm A: single myeloablative consolidation', 'Consolidation Arm B: tandem myeloablative consolidation']}, {'name': 'Filgrastim', 'type': 'BIOLOGICAL', 'otherNames': ['FILGRASTIM, LICENSE HOLDER UNSPECIFIED', 'G-CSF', 'Neupogen', 'r-metHuG-CSF', 'Recombinant Methionyl Human Granulocyte Colony Stimulating Factor', 'rG-CSF', 'Tevagrastim'], 'description': 'Given IV or SC', 'armGroupLabels': ['Consolidation Arm A: single myeloablative consolidation', 'Consolidation Arm B: tandem myeloablative consolidation']}, {'name': 'Isotretinoin', 'type': 'DRUG', 'otherNames': ['13-cis retinoic acid', '13-cis-Retinoate', '13-cis-Retinoic Acid', '13-cis-Vitamin A Acid', '13-cRA', 'Accure', 'Accutane', 'Amnesteem', 'cis-Retinoic Acid', 'Cistane', 'Claravis', 'Isotretinoinum', 'Isotrex', 'Isotrexin', 'Neovitamin A', 'Neovitamin A Acid', 'Oratane', 'Retinoicacid-13-cis', 'Ro 4-3780', 'Ro-4-3780', 'Roaccutan', 'Roaccutane', 'Roacutan', 'Sotret'], 'description': 'Given orally', 'armGroupLabels': ['Consolidation Arm A: single myeloablative consolidation', 'Consolidation Arm B: tandem myeloablative consolidation']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Consolidation Arm A: single myeloablative consolidation', 'Consolidation Arm B: tandem myeloablative consolidation']}, {'name': 'Melphalan', 'type': 'DRUG', 'otherNames': ['Alanine Nitrogen Mustard', 'CB-3025', 'L-PAM', 'L-Phenylalanine Mustard', 'L-sarcolysin', 'L-Sarcolysin Phenylalanine mustard', 'L-Sarcolysine', 'Melphalanum', 'Phenylalanine Mustard', 'Phenylalanine nitrogen mustard', 'Sarcoclorin', 'Sarkolysin', 'WR-19813'], 'description': 'Given IV', 'armGroupLabels': ['Consolidation Arm A: single myeloablative consolidation', 'Consolidation Arm B: tandem myeloablative consolidation']}, {'name': 'Peripheral Blood Stem Cell Transplantation', 'type': 'PROCEDURE', 'otherNames': ['PBPC transplantation', 'PBSCT', 'Peripheral Blood Progenitor Cell Transplantation', 'Peripheral Stem Cell Support', 'Peripheral Stem Cell Transplant', 'Peripheral Stem Cell Transplantation'], 'description': 'Undergo autologous peripheral blood stem cell transplant', 'armGroupLabels': ['Consolidation Arm A: single myeloablative consolidation', 'Consolidation Arm B: tandem myeloablative consolidation']}, {'name': 'Pharmacological Study', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Consolidation Arm A: single myeloablative consolidation', 'Consolidation Arm B: tandem myeloablative consolidation']}, {'name': 'Thiotepa', 'type': 'DRUG', 'otherNames': ["1,1',1''-Phosphinothioylidynetrisaziridine", 'Girostan', "N,N', N''-Triethylenethiophosphoramide", 'Oncotiotepa', 'STEPA', 'Tepadina', 'TESPA', 'Tespamin', 'Tespamine', 'Thio-Tepa', 'Thiofosfamide', 'Thiofozil', 'Thiophosphamide', 'Thiophosphoramide', 'Thiotef', 'Tifosyl', 'TIO TEF', 'Tio-tef', 'Triethylene thiophosphoramide', 'Triethylenethiophosphoramide', 'Tris(1-aziridinyl)phosphine sulfide', 'TSPA', 'WR 45312'], 'description': 'Given IV', 'armGroupLabels': ['Consolidation Arm B: tandem myeloablative consolidation']}, {'name': 'Topotecan Hydrochloride', 'type': 'DRUG', 'otherNames': ['Hycamptamine', 'Hycamtin', 'SKF S-104864-A', 'Topotecan HCl', 'topotecan hydrochloride (oral)'], 'description': 'Given IV', 'armGroupLabels': ['Consolidation Arm A: single myeloablative consolidation', 'Consolidation Arm B: tandem myeloablative consolidation']}, {'name': 'Vincristine Sulfate Liposome', 'type': 'DRUG', 'otherNames': ['Marqibo'], 'description': 'Given IV', 'armGroupLabels': ['Consolidation Arm A: single myeloablative consolidation', 'Consolidation Arm B: tandem myeloablative consolidation']}]}, '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': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'The University of Arizona Medical Center-University Campus', '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': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Comprehensive Cancer Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': "Miller Children's and Women's Hospital Long Beach", 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '93636', 'city': 'Madera', 'state': 'California', 'country': 'United States', 'facility': "Valley Children's Hospital", 'geoPoint': {'lat': 36.96134, 'lon': -120.06072}}, {'zip': '94609-1809', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital and Research Center at 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': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Comprehensive Cancer Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Rady Children's Hospital - San Diego", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Medical Center-Mount Zion', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Medical Center-Parnassus', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Harbor-University of California at Los Angeles Medical Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': "Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center", 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06030', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'University of Connecticut', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': "Connecticut Children's Medical Center", 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '19803', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Alfred I duPont Hospital for Children', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '20010', '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': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Broward Health Medical Center', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Lee Memorial Health System', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33908', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': "Golisano Children's Hospital of Southwest Florida", 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Health Science Center - Gainesville', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': "Memorial Regional Hospital/Joe DiMaggio Children's Hospital", 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': "Nemours Children's Clinic-Jacksonville", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Miller School of Medicine-Sylvester Cancer Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': "Nicklaus Children's Hospital", 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': "Nemours Children's Clinic - Orlando", 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'UF Cancer Center at Orlando Health', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32504', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': "Nemours Children's Clinic - Pensacola", 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '32504', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Sacred Heart Hospital', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '33701', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': "Johns Hopkins All Children's Hospital", 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': "Saint Joseph's Hospital/Children's Hospital-Tampa", 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': "Saint Mary's Hospital", 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta - Egleston", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital/Winship Cancer Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Augusta University Medical Center', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '31404', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Memorial Health University Medical Center', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Lurie Children's Hospital-Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Comprehensive Cancer Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola University Medical Center', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '61637', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Saint Jude Midwest Affiliate', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '62702', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Southern Illinois University School of Medicine', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University/Melvin and Bren Simon Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Riley Hospital for Children', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Saint Vincent Hospital and Health Care Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '50309', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': "Blank Children's Hospital", 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa/Holden Comprehensive Cancer Center', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Cancer Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky/Markey Cancer Center', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': "Norton Children's Hospital", 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane University Health Sciences Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '70118', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': "Children's Hospital New Orleans", 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '04401', 'city': 'Bangor', 'state': 'Maine', 'country': 'United States', 'facility': 'Eastern Maine Medical Center', 'geoPoint': {'lat': 44.79884, 'lon': -68.77265}}, {'zip': '04074', 'city': 'Scarborough', 'state': 'Maine', 'country': 'United States', 'facility': "Maine Children's Cancer Program", 'geoPoint': {'lat': 43.57814, 'lon': -70.32172}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland/Greenebaum Cancer Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21215', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sinai Hospital of Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University/Sidney Kimmel Cancer Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20889-5600', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Walter Reed National Military Medical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Floating Hospital for Children at Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital Cancer Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Medical School', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': "C S Mott Children's Hospital", 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University/Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48236', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Ascension Saint John Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48824-7016', 'city': 'East Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan State University Clinical Center', 'geoPoint': {'lat': 42.73698, 'lon': -84.48387}}, {'zip': '48503', 'city': 'Flint', 'state': 'Michigan', 'country': 'United States', 'facility': 'Hurley Medical Center', 'geoPoint': {'lat': 43.01253, 'lon': -83.68746}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': "Helen DeVos Children's Hospital at Spectrum Health", 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Spectrum Health at Butterworth Campus', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '49007', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Bronson Methodist Hospital', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '49008', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Kalamazoo Center for Medical Studies', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': "Children's Hospitals and Clinics of Minnesota - Minneapolis", 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota/Masonic Cancer Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri - Ellis Fischel', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospitals and Clinics", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mercy Hospital Saint Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': "Children's Hospital and Medical Center of Omaha", 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89106', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Nevada Cancer Research Foundation CCOP', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Morristown Medical Center', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': "Saint Peter's University Hospital", 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '08903', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '07112', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Newark Beth Israel Medical Center', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '07503', 'city': 'Paterson', 'state': 'New Jersey', 'country': 'United States', 'facility': "Saint Joseph's Regional Medical Center", 'geoPoint': {'lat': 40.91677, 'lon': -74.17181}}, {'zip': '07902', 'city': 'Summit', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Overlook Hospital', 'geoPoint': {'lat': 40.71562, 'lon': -74.36468}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Cancer Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical Center', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '11201', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Brooklyn Hospital Center', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': "The Steven and Alexandra Cohen Children's Medical Center of New York", 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Laura and Isaac Perlmutter Cancer Center at NYU Langone', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'State University of New York Upstate Medical University', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '10595', 'city': 'Valhalla', 'state': 'New York', 'country': 'United States', 'facility': 'New York Medical College', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}, {'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Mission Hospital Inc-Memorial Campus', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Lineberger Comprehensive Cancer Center', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Medical Center/Levine Cancer Institute', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novant Health Presbyterian Medical Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '58122', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Sanford Broadway Medical Center', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Rainbow Babies and Childrens Hospital', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '45404', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': "Dayton Children's Hospital", 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '43606', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': "The Toledo Hospital/Toledo Children's Hospital", 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '43608', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': "Mercy Children's Hospital", 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '43614', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Toledo', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Health Sciences Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97227', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': "Legacy Emanuel Children's Hospital", 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97227', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Legacy Emanuel Hospital and Health Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '18017', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lehigh Valley Hospital - Muhlenberg', 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}, {'zip': '17822', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger Medical Center', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Penn State Children's Hospital", 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19134', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Saint Christopher's Hospital for Children", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Pittsburgh of UPMC", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29203', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Prisma Health Richland Hospital', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': "BI-LO Charities Children's Cancer Center", 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Greenville Cancer Treatment Center', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '57117-5134', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Sanford USD Medical Center - Sioux Falls', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '37403', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': "T C Thompson Children's Hospital", 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37916', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'East Tennessee Childrens Hospital', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University/Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78723', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': "Dell Children's Medical Center of Central Texas", 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78411', 'city': 'Corpus Christi', 'state': 'Texas', 'country': 'United States', 'facility': "Driscoll Children's Hospital", 'geoPoint': {'lat': 27.80058, 'lon': -97.39638}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern/Simmons Cancer Center-Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': "Cook Children's Medical Center", 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '79410', 'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'facility': "Covenant Children's Hospital", 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': "Methodist Children's Hospital of South Texas", 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84113', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': "Primary Children's Hospital", 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '05405', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'University of Vermont and State Agricultural College', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia Cancer Center', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Fairfax Hospital', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}, {'zip': '23708-2197', 'city': 'Portsmouth', 'state': 'Virginia', 'country': 'United States', 'facility': 'Naval Medical Center - Portsmouth', 'geoPoint': {'lat': 36.83543, 'lon': -76.29827}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University/Massey Cancer Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '24014', 'city': 'Roanoke', 'state': 'Virginia', 'country': 'United States', 'facility': "Carilion Clinic Children's Hospital", 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': "Providence Sacred Heart Medical Center and Children's Hospital", 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '98431', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Madigan Army Medical Center', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '25304', 'city': 'Charleston', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University Charleston Division', 'geoPoint': {'lat': 38.34982, 'lon': -81.63262}}, {'zip': '54301', 'city': 'Green Bay', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Saint Vincent Hospital Cancer Center Green Bay', 'geoPoint': {'lat': 44.51916, 'lon': -88.01983}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Hospital and Clinics', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '54449', 'city': 'Marshfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Marshfield Medical Center-Marshfield', 'geoPoint': {'lat': 44.66885, 'lon': -90.1718}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Children's Hospital of Wisconsin", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': "The Children's Hospital at Westmead", 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '4029', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': "Royal Brisbane and Women's Hospital", 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '4029', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': "Royal Children's Hospital-Brisbane", 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '6008', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Princess Margaret Hospital for Children', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': 'T3B 6A8', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': "Alberta Children's Hospital", 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V6H 3V4', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "British Columbia Children's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'R3E 0V9', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'CancerCare Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'B3K 6R8', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'IWK Health Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'L8N 3Z5', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': "McMaster Children's Hospital at Hamilton Health Sciences", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'K7L 2V7', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Kingston Health Sciences Centre', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'N6A 5W9', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': "Children's Hospital", 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'N6K 1C2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Victoria Hospital', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'K1H 8L1', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': "Children's Hospital of Eastern Ontario", 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3T 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire Sainte-Justine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1V 4G2', 'city': 'Québec', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire de Quebec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '1145', 'city': 'Grafton', 'state': 'Auckland', 'country': 'New Zealand', 'facility': "Starship Children's Hospital", 'geoPoint': {'lat': -36.86029, 'lon': 174.76566}}, {'zip': '00912', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': "San Jorge Children's Hospital", 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Swiss Pediatric Oncology Group - Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Julie R Park', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Oncology Group"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Oncology Group", 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}