Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-02-18 @ 12:48 AM
Study NCT ID:
NCT00253435
Status:
COMPLETED
Last Update Posted:
2023-04-10
First Post:
2005-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
N2001-02: I-MIBG With Intensive Chemotherapy and Autologous Stem Cell Rescue 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': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'C061400', 'term': 'etoposide phosphate'}, {'id': 'D008558', 'term': 'Melphalan'}, {'id': 'D019797', 'term': '3-Iodobenzylguanidine'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'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': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D007462', 'term': 'Iodobenzenes'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006847', 'term': 'Hydrocarbons, Iodinated'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amarachelian@chla.usc.edu', 'phone': '323-3691-5687', 'title': 'Araz Marachelian, MD, NANT Medical Director', 'organization': "Chidlren's Hospital Los Angeles"}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Poor Risk Patients', 'description': 'Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.', 'otherNumAtRisk': 42, 'otherNumAffected': 42, 'seriousNumAtRisk': 42, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Good Risk Patients', 'description': 'Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.', 'otherNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Blood/Bone Marrow - Other (DELAYED ENGRAFTMENT ANC)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Blood/Bone Marrow - Other (INFUSION OF BACKUP SC FOR DELAYED ENGRAFTMENT)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Febrile neutropenia (fever of unknown origin)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 31, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Hemoglobin', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 40, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Lymphatics - Other (CAPILLARY LEAK)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Lymphatics - Other (GENERALIZED EDEMA)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Cardiac Arrhythmia - Other (MURMUR)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Cardiac Arrhythmia - Other (SINUS TACHYCARDIA)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Cardiac General - Other (SYSTOLIC MURMUR)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Supraventricular and nodal arrhythmia (Atrial tachycardia/Paroxysmal Atrial Tachycardia)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Supraventricular and nodal arrhythmia (Sinus tachycardia)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Ventricular arrhythmia (Ventricular arrhythmia NOS)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Hearing: patients with/without baseline audiogram and enrolled in a monitoring program', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Hearing: patients without baseline audiogram and not enrolled in a monitoring program', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Otitis, middle ear (non-infectious)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain (Middle ear)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Endocrine - Other (TSH)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Thyroid function, high (hyperthyroidism, thyrotoxicosis)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Ocular/Visual - Other (BILATERAL CONJUNCTIVAL HEMORRHAGE)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain (Eye)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Ascites (non-malignant)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Cheilitis', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Constipation', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Dental: teeth', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Diarrhea', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 32, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Distension/bloating, abdominal', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Dry mouth/salivary gland (xerostomia)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Dysphagia (difficulty swallowing)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Gastrointestinal - Other (HICCUPS)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Gastrointestinal - Other (LOOSE TEETH)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Gastrointestinal - Other (REFLUX)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Heartburn/dyspepsia', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Hemorrhage, GI (Lower GI NOS)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Hemorrhage, GI (Oral cavity)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Hemorrhage, GI (Stomach)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Hemorrhage, GI (Upper GI NOS)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Mucositis/stomatitis (clinical exam) (Anus)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Mucositis/stomatitis (clinical exam) (Esophagus)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Mucositis/stomatitis (clinical exam) (Oral cavity)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Mucositis/stomatitis (clinical exam) (Rectum)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Mucositis/stomatitis (functional/symptomatic) (Large bowel)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Mucositis/stomatitis (functional/symptomatic) (Oral cavity)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Mucositis/stomatitis (functional/symptomatic) (Small bowel)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Mucositis/stomatitis (functional/symptomatic) (Stomach)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Nausea', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 32, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Obstruction, GI (Small bowel NOS)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain (Abdomen NOS)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain (Esophagus)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain (Oral cavity)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain (Oral-gums)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain (Rectum)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain (Stomach)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Salivary gland changes/saliva', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Typhlitis (cecal inflammation)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Vomiting', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 33, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Constitutional Symptoms - Other (BRITTLE HAIR)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Constitutional Symptoms - Other (RHINORRHEA)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Edema:head and neck', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Edema:limb', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Edema:trunk/genital', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Fatigue (asthenia, lethargy, malaise)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Irritability (children <3 years of age)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain (Chest/thorax NOS)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain (Face)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain (Pain NOS)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain - Other (BROVIAC SITE)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain - Other (CVC SITE)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain - Other (GENERAL (NOS))', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain - Other (MOUTH PAIN)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain - Other (MUCOSITIS)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain - Other (OROPHANRIX)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain - Other (PAROTID GLAND)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain - Other (WHOLE BODY)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Rigors/chills', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Hepatobiliary/Pancreas - Other (CHOLANGITIS)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Liver dysfunction/failure (clinical)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain (Liver)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Portal vein flow', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Allergic reaction/hypersensitivity (including drug fever)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Cytokine release syndrome/acute infusion reaction', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Colitis, infectious (e.g., Clostridium difficile)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Blood)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Catheter-related)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Lung (pneumonia))', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Mucosa)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Sinus)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) (Skin (cellulitis))', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Infection - Other (ASPERGILLUS OF MOUTH)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Infection - Other (L-PRESEPTAL CELLULITIS)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Infection - Other (ORAL CANDIDA)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Infection - Other (PERIRECTAL CELLULITIS)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Infection - Other (URINE + FOR CYTOMEGALOVIRUS)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Infection - Other (VARICELLA)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils (Blood)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils (Bronchus)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils (Catheter-related)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils (Colon)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils (Lung (pneumonia))', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils (Oral cavity-gums (gingivitis))', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils (Sinus)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils (Small bowel NOS)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils (Upper airway NOS)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Infection with unknown ANC (Catheter-related)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Infection with unknown ANC (Skin (cellulitis))', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Opportunistic infection associated with >=Grade 2 Lymphopenia', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Bruising (in absence of Grade 3 or 4 thrombocytopenia)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Rash: dermatitis associated with radiation (Chemoradiation)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'ALT, SGPT (serum glutamic pyruvic transaminase)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 34, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'AST, SGOT(serum glutamic oxaloacetic transaminase)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 36, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Alkaline phosphatase', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Bilirubin (hyperbilirubinemia)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Cholesterol, serum-high (hypercholesteremia)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Creatinine', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Fibrinogen', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'GGT (gamma-Glutamyl transpeptidase)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'INR (International Normalized Ratio of prothrombin time)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Leukocytes (total WBC)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 38, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Lymphopenia', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 30, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Metabolic/Laboratory - Other (CHLORIDE)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Metabolic/Laboratory - Other (DECREASED TOTAL PROTEIN)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Metabolic/Laboratory - Other (HYPERCHLOREMIA)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Metabolic/Laboratory - Other (HYPERCHLORIDEMIA)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Metabolic/Laboratory - Other (HYPERPHOSPHATEMIA)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Metabolic/Laboratory - Other (INCREASED CHLORIDE)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Metabolic/Laboratory - Other (INCREASED FIBRINOGEN)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Metabolic/Laboratory - Other (PRE-ALBUMIN)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Neutrophils/granulocytes (ANC/AGC)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 39, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'PTT (Partial Thromboplastin Time)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Platelets', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 40, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Weight gain', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Weight loss', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Acidosis (metabolic or respiratory)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Albumin, serum-low (hypoalbuminemia)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 38, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Alkalosis (metabolic or respiratory)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Anorexia', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Bicarbonate, serum-low', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Calcium, serum-high (hypercalcemia)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Calcium, serum-low (hypocalcemia)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Dehydration', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Glucose, serum-high (hyperglycemia)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 30, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Glucose, serum-low (hypoglycemia)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Magnesium, serum-high (hypermagnesemia)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Magnesium, serum-low (hypomagnesemia)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Phosphate, serum-low (hypophosphatemia)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Potassium, serum-high (hyperkalemia)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Potassium, serum-low (hypokalemia)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 32, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Sodium, serum-high (hypernatremia)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Sodium, serum-low (hyponatremia)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 34, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Triglyceride, serum-high (hypertriglyceridemia)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Uric acid, serum-high (hyperuricemia)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Muscle weakness, generalized or specific area (not due to neuropathy) (Extremity-lower)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Muscle weakness, generalized or specific area (not due to neuropathy) (Extremity-upper)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Musculoskeletal/Soft Tissue - Other (NOT SPECIFIED)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Musculoskeletal/Soft Tissue - Other (OCCASIONAL ACHES AND PAINS)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain (Back)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain (Bone)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain (Chest wall)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain (Extremity-limb)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain (Joint)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain (Neck)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Neurology - Other (ACHY FEELING)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Neurology - Other (DYSTONIC REACTION)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Neurology - Other (GENERALIZED TENDERNESS)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Neuropathy: cranial (CN VII Motor-face; Sensory-taste)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Neuropathy: motor', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Neuropathy: sensory', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain (Head/headache)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Somnolence/depressed level of consciousness', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Syncope (fainting)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Taste alteration (dysgeusia)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Tremor', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Confusion', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Insomnia', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Mood alteration (Agitation)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Mood alteration (Anxiety)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Mood alteration (Depression)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Psychosis (hallucinations/delusions)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Bladder spasms', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Cystitis', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Hemoglobinuria', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Hemorrhage, GU (Bladder)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Hemorrhage, GU (Urinary NOS)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain (Bladder)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Proteinuria', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Renal/Genitourinary - Other (DECREASED URINE OUTPUT)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Renal/Genitourinary - Other (FLUID RETENTION)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Urinary retention (including neurogenic bladder)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain (Pelvis)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain (Penis)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain (Scrotum)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Vaginal mucositis', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Atelectasis', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Bronchospasm, wheezing', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Cough', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Dyspnea (shortness of breath)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Hemorrhage, pulmonary/upper respiratory (Nose)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Hemorrhage, pulmonary/upper respiratory (Respiratory tract NOS)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Hypoxia', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Mucositis/stomatitis (clinical exam) (Larynx)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Mucositis/stomatitis (clinical exam) (Pharynx)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Mucositis/stomatitis (functional/symptomatic) (Pharynx)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Nasal cavity/paranasal sinus reactions', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain (Larynx)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain (Throat/pharynx/larynx)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pleural effusion (non-malignant)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pneumonitis/pulmonary infiltrates', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pulmonary/Upper Respiratory - Other (CONGESTION)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pulmonary/Upper Respiratory - Other (HYPERCARBIA)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pulmonary/Upper Respiratory - Other (RHINORRHEA)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pulmonary/Upper Respiratory - Other (RUNNY NOSE)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pulmonary/Upper Respiratory - Other (TACHYPNEIC)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Dermatology/Skin - Other (DRY LIPS)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Dermatology/Skin - Other (FACIAL ABRAISIONS)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Dermatology/Skin - Other (INGROWN TOENAIL)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Dermatology/Skin - Other (LACERATION)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Dermatology/Skin - Other (PEELING SKIN)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Dermatology/Skin - Other (PERIORBITAL ECCHYMOSES)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Dermatology/Skin - Other (PSEUDOMEMBRANOUS CHANGES)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Dermatology/Skin - Other (SORE/SCAB)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Dermatology/Skin - Other (SUN BURN)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Dermatology/Skin - Other (ZOSTER LESION)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Dry skin', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Hair loss/alopecia (scalp or body)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Hyperpigmentation', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Hypopigmentation', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pruritus/itching', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Rash/desquamation', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Rash: hand-foot skin reaction', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Skin breakdown/decubitus ulcer', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Sweating (diaphoresis)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Ulceration', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Flushing', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Hematoma', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Hemorrhage/Bleeding - Other (EPISTAXIS)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Hemorrhage/Bleeding - Other (EYE)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Hemorrhage/Bleeding - Other (HEMATURIA)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Hemorrhage/Bleeding - Other (HEMOPTYSIS)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Hemorrhage/Bleeding - Other (NOSE BLEED)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Hemorrhage/Bleeding - Other (TONGUE BLEED)', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Hypertension', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Hypotension', 'notes': 'We are reporting all toxicities of all grades, whether or not they are related to the regimen or known to be related to non-treatment causes.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}], 'seriousEvents': [{'term': 'Blood/Bone Marrow - Other (DELAYED PLATELET ENGRAFTMENT)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Blood/Bone Marrow - Other (INFUSION OF BACKUP STEM CELLS)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Hepatobiliary/Pancreas - Other (HEPATOMEGALY)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils (Blood)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Infection with normal ANC or Grade 1 or 2 neutrophils (Catheter-related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Bilirubin (hyperbilirubinemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Neutrophils/granulocytes (ANC/AGC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Albumin, serum-low (hypoalbuminemia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Pain (Head/headache)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Dyspnea (shortness of breath)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v3.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Response (Complete Response, Very Good Partial Response, and Partial Response) at 60-days Post Stem Cell Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Poor Risk Patients', 'description': 'Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.'}, {'id': 'OG001', 'title': 'Good Risk Patients', 'description': 'Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Response assessed 60 days post stem cell infusion', 'description': 'Tumor response based on evaluation performed on day 60 or at the time of disease progression/recurrence or start of another treatment - whichever comes first. Such evaluations will include 123I-MIBG scan, CT/MRI, urine catecholamine measurement, and bone marrow analysis (for those with marrow disease at study entry).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One patient in the Poor Risk Cohort underwent surgery for resection (of his only measureable lesion) prior to post-treatment assessment and is not evaluable for response.'}, {'type': 'SECONDARY', 'title': 'Event-free Survival (EFS) at 3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Poor Risk Patients', 'description': 'Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.'}, {'id': 'OG001', 'title': 'Good Risk Patients', 'description': 'Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.20', 'groupId': 'OG000'}, {'value': '0.38', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 years since start of treatment', 'description': 'EFS will be measured from start of treatment until progression, death or start of another treatment - whichever comes first. We report the estimated probability of EFS at 3 years.', 'unitOfMeasure': 'Estimated probability', 'reportingStatus': 'POSTED', 'populationDescription': 'Estimated probability of 3-year progression free survival for all patients enrolled in each risk group.'}, {'type': 'SECONDARY', 'title': 'Engraftment DLT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Poor Risk Patients', 'description': 'Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.'}, {'id': 'OG001', 'title': 'Good Risk Patients', 'description': 'Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From treatment start until 60 days post stem cell infusion', 'description': '• Engraftment toxicity: delayed engraftment and/or failure to engraft defined as:\n\n* neutrophils (ANC) \\< 500/μL by day 28 post transplant, or\n* platelets \\< 20,000 /μL by day 56 post transplant, or\n* if additional stem cells are required to be infused for any medical reason prior to initial engraftment of neutrophils or platelets.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who began treatment'}, {'type': 'SECONDARY', 'title': 'Dose Limiting Veno-occlusive Disease (VOD) / Sinusoidal Obstruction Syndrome SOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Poor Risk Patients', 'description': 'Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.'}, {'id': 'OG001', 'title': 'Good Risk Patients', 'description': 'Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Between start of MIBG treatment and 60 days post stem cell infusion', 'description': 'Dose limiting veno-occlusive disease (VOD) defined as:\n\n* the presence of hepatomegaly with right upper quadrant tenderness and an elevation of total bilirubin \\> grade 1, PLUS\n* the presence of grade 3 abnormalities of any ONE of the following: total bilirubin, hypoalbuminemia, weight gain, or hypoxia without other attribution', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who began treatment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Poor Risk Patients', 'description': 'Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.'}, {'id': 'FG001', 'title': 'Good Risk Patients', 'description': 'Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Total number is 42', 'groupId': 'FG000', 'numSubjects': '42'}, {'comment': 'This cohort opened as long as the poor risk group is open to accrual.', 'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': '1st Interim Analysis', 'achievements': [{'comment': 'First interim analysis: need 2+ responses in first 15 patients. Goal met study continued.', 'groupId': 'FG000', 'numSubjects': '15'}, {'comment': 'Only interim analysis: need 1+ response in first 10 patients.', 'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': '2nd Interim Analysis', 'achievements': [{'comment': 'Second interim analysis: need 3+ responses in first 25 patients. Goal met study continued.', 'groupId': 'FG000', 'numSubjects': '10'}, {'comment': 'This cohort opened as long as the poor risk group is open to accrual.', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': '3rd Interim Analysis', 'achievements': [{'comment': 'Third interim analysis: need 4+ responses in first 35 patients. Goal met study continued.', 'groupId': 'FG000', 'numSubjects': '10'}, {'comment': 'This cohort opened as long as the poor risk group is open to accrual.', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Forty-two evaluable poor risk patients enrolled.', 'groupId': 'FG000', 'numSubjects': '42'}, {'comment': 'Eight evaluable patients enrolled.', 'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Opened to accrual on 12/10/04 \\& closed to accrual on 07/21/10; suspended 6 times for amendments. Opened at 12 NANT institutions.\n\n1st patient started on treatment on 03/11/05. 50 patients enrolled; all eligible \\& evaluable for toxicity. 49 patients were evaluable for response.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Poor Risk Patients', 'description': 'Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.'}, {'id': 'BG001', 'title': 'Good Risk Patients', 'description': 'Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'groupId': 'BG000', 'lowerLimit': '1.1', 'upperLimit': '22.8'}, {'value': '7.7', 'groupId': 'BG001', 'lowerLimit': '4.3', 'upperLimit': '16.4'}, {'value': '6.0', 'groupId': 'BG002', 'lowerLimit': '1.1', 'upperLimit': '22.8'}]}]}], 'paramType': 'MEDIAN', 'description': 'Age (in years) at time of treatment start.', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'GFR Status', 'classes': [{'title': 'Normal GFR', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}, {'title': 'Low GFR', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Pre-therapy glomerular filtration rate:\n\nNormal GFR: \\>= 100 ml/min/1.73 m2 \\& Low GFR: 60-99 ml/min/1.73 m2', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Number of patients who signed the consent form and started treatment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-06', 'studyFirstSubmitDate': '2005-11-11', 'resultsFirstSubmitDate': '2014-08-25', 'studyFirstSubmitQcDate': '2005-11-11', 'lastUpdatePostDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-08-23', 'studyFirstPostDateStruct': {'date': '2005-11-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response (Complete Response, Very Good Partial Response, and Partial Response) at 60-days Post Stem Cell Infusion', 'timeFrame': 'Response assessed 60 days post stem cell infusion', 'description': 'Tumor response based on evaluation performed on day 60 or at the time of disease progression/recurrence or start of another treatment - whichever comes first. Such evaluations will include 123I-MIBG scan, CT/MRI, urine catecholamine measurement, and bone marrow analysis (for those with marrow disease at study entry).'}], 'secondaryOutcomes': [{'measure': 'Event-free Survival (EFS) at 3 Years', 'timeFrame': '3 years since start of treatment', 'description': 'EFS will be measured from start of treatment until progression, death or start of another treatment - whichever comes first. We report the estimated probability of EFS at 3 years.'}, {'measure': 'Engraftment DLT', 'timeFrame': 'From treatment start until 60 days post stem cell infusion', 'description': '• Engraftment toxicity: delayed engraftment and/or failure to engraft defined as:\n\n* neutrophils (ANC) \\< 500/μL by day 28 post transplant, or\n* platelets \\< 20,000 /μL by day 56 post transplant, or\n* if additional stem cells are required to be infused for any medical reason prior to initial engraftment of neutrophils or platelets.'}, {'measure': 'Dose Limiting Veno-occlusive Disease (VOD) / Sinusoidal Obstruction Syndrome SOS', 'timeFrame': 'Between start of MIBG treatment and 60 days post stem cell infusion', 'description': 'Dose limiting veno-occlusive disease (VOD) defined as:\n\n* the presence of hepatomegaly with right upper quadrant tenderness and an elevation of total bilirubin \\> grade 1, PLUS\n* the presence of grade 3 abnormalities of any ONE of the following: total bilirubin, hypoalbuminemia, weight gain, or hypoxia without other attribution'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['recurrent neuroblastoma'], 'conditions': ['Neuroblastoma']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radioactive drugs, such as iodine I 131 metaiodobenzylguanidine, may carry radiation directly to tumor cells and not harm normal cells. Drugs used in chemotherapy, such as carboplatin, etoposide, and melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. An autologous peripheral stem cell or bone marrow transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy. Giving iodine I 131 metaiodobenzylguanidine and combination chemotherapy with an autologous peripheral stem cell or bone marrow transplant may allow more chemotherapy to be given so that more tumor cells are killed. Giving radiation therapy after an autologous peripheral stem cell or bone marrow transplant may kill any remaining tumor cells.\n\nPURPOSE: This phase II trial is studying how well giving iodine I 131 metaiodobenzylguanidine together with combination chemotherapy and radiation therapy works in treating patients who are undergoing an autologous peripheral stem cell or bone marrow transplant for relapsed or refractory neuroblastoma.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the response rate in patients with relapsed or refractory neuroblastoma treated with iodine I 131 metaiodobenzylguanidine (\\^131I-MIBG) and combination chemotherapy comprising carboplatin, etoposide, and melphalan followed by autologous bone marrow or peripheral blood stem cell transplantation and radiotherapy.\n\nSecondary\n\n* Determine the hematopoietic and nonhematopoietic toxicity of this regimen in these patients.\n* Determine the tumor self-absorbed radiation dose (TSARD) in patients with measurable soft tissue lesions treated with this regimen.\n* Correlate the TSARD with tumor response in patients with measurable residual soft tissue disease treated with this regimen.\n\nOUTLINE: This is a multicenter study. Patients are stratified according to risk (poor-risk group \\[mixed or no response to induction therapy or progression during or after induction therapy\\] vs good-risk group \\[partial response after 4 courses of induction therapy\\]) and kidney function at study entry (glomerular filtration rate \\[GFR\\] ≥ 100 mL/min vs GFR 60-99 mL/min)\n\n* Stem cell harvest: Patients undergo a peripheral blood stem cell harvest or bone marrow harvest provided they have an adequate number of cells available. At least 2 weeks later, patients proceed to iodine I 131 metaiodobenzylguanidine (\\^131I-MIBG) and combination chemotherapy.\n* 131I-MIBG and combination chemotherapy: Patients receive \\^131I-MIBG IV over 2 hours on day -21, carboplatin IV continuously on days -7 to -4, etoposide IV continuously on days -7 to -4, and melphalan IV over 1 hour on days -7 to -5.\n* Stem cell infusion and filgrastim (G-CSF): Three days after completion of chemotherapy, patients undergo transplantation of either stem cells or bone marrow on day 0. Patients also receive G-CSF subcutaneously or IV over 1 hour once daily beginning on day 0 and continuing until blood counts return to normal.\n* Radiotherapy: Once blood counts return to normal, patients undergo radiotherapy to primary and metastatic sites that have not received previous irradiation over 12 days beginning after day 42.\n\nAfter completion of study treatment, patients are followed for 2 years and then periodically thereafter.\n\nPROJECTED ACCRUAL: Approximately 50 patients (40 low-risk patients and 8-10 high-risk patients) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '29 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of relapsed or refractory neuroblastoma\n\n * Histologically confirmed and/or demonstration of tumor cells in bone marrow with elevated urinary catecholamine metabolites\n * High-risk neuroblastoma must meet one of the following:\n\n * Progressive disease prior to or after completion of induction therapy\n * Mixed response or no response after completion of 4 courses of induction therapy\n * Partial response after 4 courses of induction therapy allowed provided no prior participation in COG-A3973 or other phase III COG trials\n* Measurable disease, defined as at least one metaiodobenzylguanidine (MIBG)-avid target lesion determined by diagnostic MIBG scan within 6 weeks of study entry (tumor sites that have received local irradiation within 3 months of study entry are not considered target lesions)\n\nPATIENT CHARACTERISTICS:\n\nPerformance status\n\n* Lansky 60-100% OR\n* Karnofsky 60-100%\n\nLife expectancy\n\n* At least 2 months\n\nHematopoietic\n\n* Hemoglobin ≥ 10 g/dL\n* Absolute neutrophil count ≥ 750/mm\\^3\n* Platelet count ≥ 50,000/mm\\^3 (if no marrow involvement by morphologic exam/no transfusion allowed) (\\> 20,000/mm\\^3 if metastatic tumor involvement of marrow by morphologic exam/transfusion allowed)\n\nHepatic\n\n* Bilirubin \\< 1.3 mg/dL\n* SGOT and SGPT \\< 5 times normal\n* Hepatitis B surface antigen negative\n* Hepatitis C negative\n\nRenal\n\n* Glomerular filtration rate or creatinine clearance ≥ 60 ml/min\n* Creatinine ≤ 1.5 times normal for age as follows:\n\n * 0.8 mg/dL (for patients ≤ 5 years of age)\n * 1.0 mg/dL (for patients 6 to 10 years of age)\n * 1.2 mg/dL (for patients 11 to 15 years of age)\n * 1.5 mg/dL (for patients \\> 15 years of age)\n\nCardiovascular\n\n* Ejection fraction ≥ 55% by echocardiogram or radionuclide MUGA OR\n* Fractional shortening ≥ 27% by echocardiogram\n\nPulmonary\n\n* Normal lung function defined as no dyspnea at rest and no oxygen requirement OR measured oxygen saturation \\> 93% on room air\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No disease of any major organ system that would preclude study compliance\n* No concurrent hemodialysis\n* No active infection requiring IV antivirals, antibiotics, or antifungals (patients on antifungal therapy are eligible provided they are culture- and biopsy-negative in suspected residual radiographic lesions)\n* Patient weight within limits to receive ≤ maximum total allowable dose of \\^131I-MIBG\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No prior myeloablative transplantation\n\n * Prior submyeloablative transplantation allowed at discretion of principal investigator\n* More than 3 weeks since prior biologic therapy\n\nChemotherapy\n\n* More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for mitomycin C or nitrosoureas)\n* No prior melphalan therapy with a total dose of \\> 100 mg/m\\^2\n\nRadiotherapy\n\n* See Disease Characteristics\n* At least 6 weeks since prior radiotherapy (6 months for craniospinal or whole lung radiotherapy)\n* No prior total body irradiation\n* No prior iodine I 131 MIBG (\\^131I-MIBG)\n* No prior total abdominal or whole liver radiotherapy\n* No prior local radiotherapy, including any of the following:\n\n * 1200 cGy to more than 33% of both kidneys (patient must have at least one kidney that has not exceeded the dose/volume of radiation listed)\n * 1800 cGy to more than 30% of liver and/or 900 cGy to more than 50% of liver\n\nOther\n\n* Recovered from all prior therapy\n* No medications with a potential interference of \\^131I-MIBG uptake 1 week before and 2 weeks after completion of \\^131I-MIBG'}, 'identificationModule': {'nctId': 'NCT00253435', 'briefTitle': 'N2001-02: I-MIBG With Intensive Chemotherapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Los Angeles"}, 'officialTitle': 'I-Metaiodobenzylguanidine (MIBG) With Intensive Chemotherapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma', 'orgStudyIdInfo': {'id': 'CDR0000450148'}, 'secondaryIdInfos': [{'id': 'P01CA081403', 'link': 'https://reporter.nih.gov/quickSearch/P01CA081403', 'type': 'NIH'}, {'id': 'N2001-02', 'type': 'OTHER', 'domain': 'NANT Consortium'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All the patients enrolled in the study', 'description': 'This is a single arm study. The following description applies to all the patients who are enrolled in the study:\n\nOn Day -21, patients receive 131I-MIBG infusion.\n\nOn Day -7, Day -6, Day -5, patients receive Carboplatin, Etoposide, Melphalan.\n\nOn Day -4, patients receive Carboplatin, Etoposide.\n\nOn Day -3, Day -2, Day -1, patients rest.\n\nOn Day 0, patients receive peripheral blood stem cell infusion.\n\nDosing of Carboplatin, Etoposide and Melphalan is based upon whole body dosimetry (cGy) estimates.\n\nFilgrastim 5 micrograms/kg/day S.C. or IV will be given daily beginning on Day 0.\n\nLocal radiation therapy is to be given to previously non-irradiated primary and metastatic sites of disease.', 'interventionNames': ['Biological: Filgrastim', 'Drug: Carboplatin', 'Drug: Etoposide', 'Drug: Melphalan', 'Procedure: Peripheral blood stem cell infusion', 'Radiation: 131I-MIBG', 'Radiation: Radiation therapy']}], 'interventions': [{'name': 'Filgrastim', 'type': 'BIOLOGICAL', 'otherNames': ['G-CSF'], 'description': 'Filgrastim 5 micrograms/kg/day S.C. or IV will be given daily beginning on Day 0. The first dose should begin four hours after the stem cell infusion is completed. Filgrastim will continue daily until the ANC \\>=1500/uL for three consecutive days.', 'armGroupLabels': ['All the patients enrolled in the study']}, {'name': 'Carboplatin', 'type': 'DRUG', 'otherNames': ['cis-diammine; Paraplatin; Paraplatin-AQ'], 'description': 'The carboplatin will be administered as a continuous IV infusion Day - 7 through Day - 4, with dosing based upon pretreatment GFR levels. The carboplatin should be diluted to a concentration of 0.3 mg/ml in D5W 0.45NS and infused concomitantly with etoposide through the same central venous catheter using a "Y" connector; a controlled rate infusion pump is used for each arm of the "Y".', 'armGroupLabels': ['All the patients enrolled in the study']}, {'name': 'Etoposide', 'type': 'DRUG', 'otherNames': ['VP-16; Etopophos'], 'description': 'The etoposide shall be administered day -7 through day -4 via continuous intravenous infusion over 96 hours. For patients with a corrected GFR \\>= 100 ml/min/1.72 m\\^2, a dose of 300 mg/m\\^2/day (10 mg/kg/day if child is \\< 12 kg) shall be given. For patients with a corrected GFR 60-99 ml/min/1.72 m\\^2, the etoposide will be administered at a dose of 160 mg/m\\^2/day (5.3 mg/kg/day). The etoposide will be diluted in D5W 0.45%NS at a concentration of \\< 0.4 mg/ml. Etoposide should not be mixed with carboplatin, but administered using a Y-connector.', 'armGroupLabels': ['All the patients enrolled in the study']}, {'name': 'Melphalan', 'type': 'DRUG', 'otherNames': ['L-phenylalanine mustard; L-PAM; Alkeran; Sarcolysin'], 'description': 'For patients in either the normal GFR strata (\\>=100 ml/min/1.73 m\\^2), or reduced GFR strata (60-99 ml/min/1.73m\\^2), melphalan shall be administered at a dose of 60 mg/m\\^2/day (2 mg/kg/day if child is \\< 12 kg) on day -7, -6, and -5 of study. The melphalan should be infused at a rate of less than 10 mg/minute, and should complete within 1 hour of reconstitution each day. The melphalan should be diluted in 0.9% NaCl at a concentration \\< 2 mg/ml. The total dosage of melphalan to be administered will be 180 mg/m\\^2.', 'armGroupLabels': ['All the patients enrolled in the study']}, {'name': 'Peripheral blood stem cell infusion', 'type': 'PROCEDURE', 'description': 'Stem cells or marrow will be infused on day 0 of study therapy. Where the DMSO concentration in the stem cell product would exceed accepted level for infusion within a 24 hour period, stem cell products may be infused over two days to meet this standard. For purged PBSC: A minimum of 2.0 x 10\\^6 viable CD34+ cells/kg must be available. For unpurged PBSC, a minimum of 2.0 x 10\\^6 viable CD34+ cells/kg must be available. Having a back-up of 2.0 x 10\\^6 viable CD34+ cells/kg purged or unpurged PBSC is recommended but not required. For purged bone marrow, a minimum of 1.5 x10\\^8 mononuclear cells/kg must be available.', 'armGroupLabels': ['All the patients enrolled in the study']}, {'name': '131I-MIBG', 'type': 'RADIATION', 'otherNames': ['Iobenguane I 131'], 'description': 'Therapeutic 131I MIBG will be synthesized by Draximage Canada.with specific activity between 15 and 25mCi/ml. Radiopurity will be initially determined by Draximage, prior to shipment to participating centers. Free radioiodide content must then be rechecked at the treating center prior to infusion using HPLC or Sep-Pac methodology.', 'armGroupLabels': ['All the patients enrolled in the study']}, {'name': 'Radiation therapy', 'type': 'RADIATION', 'description': 'Local irradiation is to be given to previously non-irradiated primary and metastatic sites of disease. Local irradiation should not start till the patient is medically stable, has an ANC \\> 1000/uL, platelets \\> 30,000 / uL, and is \\> 42 days post transplant. Recommended radiation guidelines consist of 2160 cGy total, given over 12 days using a single 180 cGy fraction/day. Any delay in local radiation that would extend treatment beyond day +84 should be discussed with the study chair. Local radiation will be administered at a participating NANT member site.', 'armGroupLabels': ['All the patients enrolled in the study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027-0700', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Childrens Hospital Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': "Lucile Packard Children's Hospital at Stanford University Medical Center", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Helen Diller Family Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "University of Chicago Comer Children's Hospital", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109-0286', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': "C.S. Mott Children's Hospital at University of Michigan Medical Center", 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "Morgan Stanley Children's Hospital of New York-Presbyterian", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45229-3039', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19104-4318', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': "Cook Children's Medical Center - Fort Worth", 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77030-2399', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Children's Hospital and Regional Medical Center - Seattle", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53792-6164', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Paul P. Carbone Comprehensive Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Gregory Yanik, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Michigan Rogel Cancer Center'}, {'name': 'Katherine K. Matthay, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'John M. Maris, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Los Angeles", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'NANT Operations Center', 'investigatorFullName': 'Nant Operations Center', 'investigatorAffiliation': "Children's Hospital Los Angeles"}}}}