Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2025-12-28 @ 8:07 AM
Study NCT ID:
NCT01601535
Status:
COMPLETED
Last Update Posted:
2019-07-31
First Post:
2012-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of MLN8237 in Combination With Irinotecan and Temozolomide
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': 'C550258', 'term': 'MLN 8237'}, {'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D000077204', 'term': 'Temozolomide'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nantops@chla.usc.edu', 'phone': '323-361-5687', 'title': 'NANT Medical Director', 'organization': 'New Approaches to Neuroblastoma Therapy'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From date of study enrollment to the date of progression or withdrawal from the study, up to 34 cycles (about 2 years).', 'eventGroups': [{'id': 'EG000', 'title': 'DL 1', 'description': 'alisertib tablets (45 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis optional', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'DL 1B', 'description': 'alisertib tablets (45 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'DL 2B', 'description': 'alisertib tablets (60 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'DL 3B', 'description': 'alisertib tablets (80 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Ph 2', 'description': 'alisertib tablets (60 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 20, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Oral Solution', 'description': 'alisertib oral solution (45 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anemia', 'notes': 'As requested, 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': 6, 'numEvents': 50, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 61, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 100, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 17, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 147, 'numAffected': 19}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 41, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Febrile neutropenia', 'notes': 'As requested, 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': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hemolysis', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Palpitations', 'notes': 'As requested, 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': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Sinus tachycardia', 'notes': 'As requested, 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': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 22, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 9, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Ear pain', 'notes': 'As requested, 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': 6, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hypothyroidism', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Blurred vision', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 13, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Conjunctivitis', 'notes': 'As requested, 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': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Dry eye', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Eye disorders - Other, specify', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Eye pain', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Photophobia', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Abdominal distension', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Abdominal pain', 'notes': 'As requested, 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': 6, 'numEvents': 17, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 20, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 17, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 9, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Anal pain', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Colitis', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Constipation', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Dental caries', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Diarrhea', 'notes': 'As requested, 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': 6, 'numEvents': 45, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 27, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 50, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 14, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 88, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 27, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Dry mouth', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Dyspepsia', 'notes': 'As requested, 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': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Enterocolitis', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Flatulence', 'notes': 'As requested, 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': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Gastroesophageal reflux disease', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Gastrointestinal disorders - Other, specify', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Mucositis oral', 'notes': 'As requested, 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': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 18, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 11, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Nausea', 'notes': 'As requested, 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': 6, 'numEvents': 33, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 37, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 52, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 11, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 98, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 17, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Oral dysesthesia', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Oral hemorrhage', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Oral pain', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Rectal hemorrhage', 'notes': 'As requested, 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': 6, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Rectal pain', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Stomach pain', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Toothache', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Vomiting', 'notes': 'As requested, 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': 6, 'numEvents': 29, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 38, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 34, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 68, 'numAffected': 17}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 24, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Chills', 'notes': 'As requested, 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': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Edema face', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Edema trunk', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Facial pain', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Fatigue', 'notes': 'As requested, 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': 6, 'numEvents': 10, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 24, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 12, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 23, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Fever', 'notes': 'As requested, 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': 6, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 10, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'General disorders and administration site conditions - Other, specify', 'notes': 'As requested, 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': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Infusion related reaction', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Infusion site extravasation', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Irritability', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Malaise', 'notes': 'As requested, 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': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Non-cardiac chest pain', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Pain', 'notes': 'As requested, 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': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Conjunctivitis infective', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Enterocolitis infectious', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Infections and infestations - Other, specify', 'notes': 'As requested, 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': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Lung infection', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Mucosal infection', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Otitis externa', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Otitis media', 'notes': 'As requested, 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': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Rhinitis infective', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Sepsis', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Skin infection', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Upper respiratory infection', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 8, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Urinary tract infection', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Vaginal infection', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Bruising', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 9, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Burn', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Fall', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Vascular access complication', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Activated partial thromboplastin time prolonged', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Alanine aminotransferase increased', 'notes': 'As requested, 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': 6, 'numEvents': 36, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 32, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 51, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 112, 'numAffected': 18}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 23, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Alkaline phosphatase increased', 'notes': 'As requested, 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': 6, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 32, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Aspartate aminotransferase increased', 'notes': 'As requested, 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': 6, 'numEvents': 42, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 23, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 51, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 103, 'numAffected': 17}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 22, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Blood bilirubin increased', 'notes': 'As requested, 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': 6, 'numEvents': 17, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 11, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Creatinine increased', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 27, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Electrocardiogram QT corrected interval prolonged', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'GGT increased', 'notes': 'As requested, 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': 6, 'numEvents': 12, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hemoglobin increased', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Investigations - Other, specify', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Lymphocyte count decreased', 'notes': 'As requested, 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': 6, 'numEvents': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 21, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 43, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 14, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 111, 'numAffected': 17}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 26, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Lymphocyte count increased', 'notes': 'As requested, 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': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 8, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Neutrophil count decreased', 'notes': 'As requested, 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': 6, 'numEvents': 43, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 46, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 66, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 15, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 132, 'numAffected': 20}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 41, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Platelet count decreased', 'notes': 'As requested, 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': 6, 'numEvents': 43, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 55, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 93, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 16, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 154, 'numAffected': 20}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 43, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Weight gain', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Weight loss', 'notes': 'As requested, 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': 6, 'numEvents': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 13, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 9, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'White blood cell decreased', 'notes': 'As requested, 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': 6, 'numEvents': 55, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 57, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 89, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 15, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 150, 'numAffected': 20}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 45, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Acidosis', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Anorexia', 'notes': 'As requested, 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': 6, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 40, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 9, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 25, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 17, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Dehydration', 'notes': 'As requested, 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': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hypercalcemia', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hyperglycemia', 'notes': 'As requested, 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': 6, 'numEvents': 11, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 22, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 27, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hyperkalemia', 'notes': 'As requested, 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': 6, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hypermagnesemia', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 17, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 11, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hypernatremia', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 10, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hypertriglyceridemia', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hypoalbuminemia', 'notes': 'As requested, 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': 6, 'numEvents': 18, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 18, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 19, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 14, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hypocalcemia', 'notes': 'As requested, 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': 6, 'numEvents': 27, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 29, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 22, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hypoglycemia', 'notes': 'As requested, 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': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 13, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hypokalemia', 'notes': 'As requested, 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': 6, 'numEvents': 29, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 14, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 26, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hypomagnesemia', 'notes': 'As requested, 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': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 10, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hyponatremia', 'notes': 'As requested, 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': 6, 'numEvents': 11, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 10, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hypophosphatemia', 'notes': 'As requested, 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': 6, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 15, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Metabolism and nutrition disorders - Other, specify', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Back pain', 'notes': 'As requested, 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': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Bone pain', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Chest wall pain', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Generalized muscle weakness', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Muscle weakness lower limb', 'notes': 'As requested, 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': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Musculoskeletal and connective tissue disorder - Other, specify', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Neck pain', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Pain in extremity', 'notes': 'As requested, 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': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 25, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Tumor pain', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 9, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Depressed level of consciousness', 'notes': 'As requested, 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': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Dizziness', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Dysgeusia', 'notes': 'As requested, 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': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Headache', 'notes': 'As requested, 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': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 9, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 11, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 18, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Nervous system disorders - Other, specify', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Paresthesia', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Peripheral motor neuropathy', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Peripheral sensory neuropathy', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Presyncope', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Somnolence', 'notes': 'As requested, 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': 6, 'numEvents': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Syncope', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Tremor', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Agitation', 'notes': 'As requested, 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': 6, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Anxiety', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 9, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Depression', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hallucinations', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Insomnia', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Psychiatric disorders - Other, specify', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Restlessness', 'notes': 'As requested, 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': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Acute kidney injury', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hematuria', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 24, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Proteinuria', 'notes': 'As requested, 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': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 23, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Urinary retention', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Urinary tract pain', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Urine discoloration', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Penile pain', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Allergic rhinitis', 'notes': 'As requested, 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': 6, 'numEvents': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 13, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 14, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Apnea', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Atelectasis', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Bronchospasm', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Cough', 'notes': 'As requested, 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': 6, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 13, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 29, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 9, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 14, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Dyspnea', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Epistaxis', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 16, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Nasal congestion', 'notes': 'As requested, 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': 6, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 10, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Pharyngeal mucositis', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Pharyngolaryngeal pain', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Postnasal drip', 'notes': 'As requested, 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': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Respiratory, thoracic and mediastinal disorders - Other, specify', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 22, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Sore throat', 'notes': 'As requested, 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': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Alopecia', 'notes': 'As requested, 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': 6, 'numEvents': 38, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 52, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 12, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 86, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 32, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Bullous dermatitis', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Dry skin', 'notes': 'As requested, 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': 6, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 9, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 8, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 18, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Palmar-plantar erythrodysesthesia syndrome', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Pruritus', 'notes': 'As requested, 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': 6, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Rash acneiform', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Rash maculo-papular', 'notes': 'As requested, 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': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 7, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Skin and subcutaneous tissue disorders - Other, specify', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 11, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Skin hyperpigmentation', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Skin ulceration', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Urticaria', 'notes': 'As requested, 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': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Surgical and medical procedures - Other, specify', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Flushing', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hematoma', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hypertension', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hypotension', 'notes': 'As requested, 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': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 7, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 7, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}], 'seriousEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Catheter related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Infections and infestations - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Movements involuntary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Pharyngeal mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Tolerated Dose (MTD) When Given Together With Fixed Doses of Irinotecan and Temozolomide in Children and Young Adults With Relapsed or Refractory Neuroblastoma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I', 'description': 'Patients received alisertib tablets at dose levels of 45, 60, and 80 mg/m\\^2 per day on days 1 to 7 along with irinotecan 50 mg/m\\^2 intravenously and temozolomide 100 mg/m\\^2 orally on days 1 to 5.'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '21 days, from study day 1', 'description': 'The MTD was the highest dose level tested at which fewer than two of six patients had first course DLT. Hematologic DLT was defined as grade 4 neutropenia for more than 7 days, need for platelet transfusion for a platelet count of less than 20,000/mL twice within a 7-day period, or greater than 14-day delay in the start of a subsequent course because of neutropenia or thrombocytopenia. Nonhematologic DLT was defined as any nonhematologic toxicity that delayed the start of a subsequent cycle by more than 14 days or any grade ≥3 toxicity with the exception of the following grade 3 toxicities: nausea, vomiting, anorexia, or dehydration resolving to grade ≤ 2 within 72 hours; increase in hepatic transaminase or electrolyte abnormality resolving to grade ≤ 1 within 7 days; diarrhea persisting for less than 72 hours; fever; infection; or febrile neutropenia. DLT definitions included only toxicities deemed at least possibly related to therapy.', 'unitOfMeasure': 'mg/m^2', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Dose Limiting Toxicity (DLT) Data Associated With the Determination of the Recommended Phase 2 Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DL 1', 'description': 'alisertib tablets (45 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis optional'}, {'id': 'OG001', 'title': 'DL 1B', 'description': 'alisertib tablets (45 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}, {'id': 'OG002', 'title': 'DL 2B', 'description': 'alisertib tablets (60 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}, {'id': 'OG003', 'title': 'DL 3B', 'description': 'alisertib tablets (80 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '21 days, from study day 1', 'description': 'The MTD was the highest dose level tested at which fewer than two of six patients had first course DLT. Hematologic DLT was defined as grade 4 neutropenia for more than 7 days, need for platelet transfusion for a platelet count of less than 20,000/mL twice within a 7-day period, or greater than 14-day delay in the start of a subsequent course because of neutropenia or thrombocytopenia. Nonhematologic DLT was defined as any nonhematologic toxicity that delayed the start of a subsequent cycle by more than 14 days or any grade ≥3 toxicity with the exception of the following grade 3 toxicities: nausea, vomiting, anorexia, or dehydration resolving to grade ≤ 2 within 72 hours; increase in hepatic transaminase or electrolyte abnormality resolving to grade ≤ 1 within 7 days; diarrhea persisting for less than 72 hours; fever; infection; or febrile neutropenia. DLT definitions included only toxicities deemed at least possibly related to therapy.', 'unitOfMeasure': 'DLTs', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics When Given Together With Fixed Doses of Irinotecan and Temozolomide in Children and Young Adults With Relapsed or Refractory Neuroblastoma: Alisertib Day 4 Trough, Day 5 Trough and Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'DL 1', 'description': 'alisertib tablets (45 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis optional'}, {'id': 'OG001', 'title': 'DL 1B', 'description': 'alisertib tablets (45 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}, {'id': 'OG002', 'title': 'DL 2B', 'description': 'alisertib tablets (60 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}, {'id': 'OG003', 'title': 'DL 3B', 'description': 'alisertib tablets (80 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}, {'id': 'OG004', 'title': 'Oral Solution', 'description': 'alisertib oral solution (45 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}], 'classes': [{'title': 'Alisertib Day 4 trough', 'categories': [{'measurements': [{'value': '0.48', 'groupId': 'OG000', 'lowerLimit': '0.09', 'upperLimit': '0.98'}, {'value': '0.35', 'groupId': 'OG001', 'lowerLimit': '0.13', 'upperLimit': '1.38'}, {'value': '0.3', 'groupId': 'OG002', 'lowerLimit': '0.22', 'upperLimit': '4.07'}, {'value': '0.73', 'groupId': 'OG003', 'lowerLimit': '0.15', 'upperLimit': '1.35'}, {'value': '0.47', 'groupId': 'OG004', 'lowerLimit': '0.09', 'upperLimit': '3.37'}]}]}, {'title': 'Alisertib Day 5 trough', 'categories': [{'measurements': [{'value': '0.37', 'groupId': 'OG000', 'lowerLimit': '0.12', 'upperLimit': '1.36'}, {'value': '0.36', 'groupId': 'OG001', 'lowerLimit': '0.18', 'upperLimit': '0.65'}, {'value': '0.2', 'groupId': 'OG002', 'lowerLimit': '0.05', 'upperLimit': '3.31'}, {'value': '0.69', 'groupId': 'OG003', 'lowerLimit': '0.25', 'upperLimit': '1.27'}, {'value': '0.58', 'groupId': 'OG004', 'lowerLimit': '0.09', 'upperLimit': '3.2'}]}]}, {'title': 'Alisertib Cmax', 'categories': [{'measurements': [{'value': '2.56', 'groupId': 'OG000', 'lowerLimit': '1.91', 'upperLimit': '5.92'}, {'value': '2.39', 'groupId': 'OG001', 'lowerLimit': '1.72', 'upperLimit': '5.92'}, {'value': '3.77', 'groupId': 'OG002', 'lowerLimit': '2.16', 'upperLimit': '6.76'}, {'value': '4.94', 'groupId': 'OG003', 'lowerLimit': '3.99', 'upperLimit': '6.22'}, {'value': '8.66', 'groupId': 'OG004', 'lowerLimit': '3.49', 'upperLimit': '11.39'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1st week of cycle 1', 'description': 'Outcomes included Alisertib, irinotecan, APC, SN-38, and SN-38G. APC, SN-38, and SN-38G are metabolites of irinotecan.', 'unitOfMeasure': 'µM', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics When Given Together With Fixed Doses of Irinotecan and Temozolomide in Children and Young Adults With Relapsed or Refractory Neuroblastoma: Alisertib Tmax and Half-life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'DL 1', 'description': 'alisertib tablets (45 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis optional'}, {'id': 'OG001', 'title': 'DL 1B', 'description': 'alisertib tablets (45 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}, {'id': 'OG002', 'title': 'DL 2B', 'description': 'alisertib tablets (60 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}, {'id': 'OG003', 'title': 'DL 3B', 'description': 'alisertib tablets (80 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}, {'id': 'OG004', 'title': 'Oral Solution', 'description': 'alisertib oral solution (45 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}], 'classes': [{'title': 'Alisertib Tmax', 'categories': [{'measurements': [{'value': '2.04', 'groupId': 'OG000', 'lowerLimit': '1.12', 'upperLimit': '6.93'}, {'value': '1.74', 'groupId': 'OG001', 'lowerLimit': '0.65', 'upperLimit': '2.9'}, {'value': '2.5', 'groupId': 'OG002', 'lowerLimit': '0.97', 'upperLimit': '4'}, {'value': '2.52', 'groupId': 'OG003', 'lowerLimit': '2', 'upperLimit': '3.03'}, {'value': '2', 'groupId': 'OG004', 'lowerLimit': '0.5', 'upperLimit': '4'}]}]}, {'title': 'Alisertib Half-life', 'categories': [{'measurements': [{'value': '7.20', 'groupId': 'OG000', 'lowerLimit': '5.22', 'upperLimit': '9.83'}, {'value': '8.61', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '18.2'}, {'value': '6.19', 'groupId': 'OG002', 'lowerLimit': '3.65', 'upperLimit': '20.28'}, {'value': '8.54', 'groupId': 'OG003', 'lowerLimit': '5.35', 'upperLimit': '10.05'}, {'value': '8.34', 'groupId': 'OG004', 'lowerLimit': '4.28', 'upperLimit': '16.89'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1st week of cycle 1', 'description': 'Outcomes included Alisertib, irinotecan, APC, SN-38, and SN-38G. APC, SN-38, and SN-38G are metabolites of irinotecan.', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics When Given Together With Fixed Doses of Irinotecan and Temozolomide in Children and Young Adults With Relapsed or Refractory Neuroblastoma: Alisertib AUC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'DL 1', 'description': 'alisertib tablets (45 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis optional'}, {'id': 'OG001', 'title': 'DL 1B', 'description': 'alisertib tablets (45 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}, {'id': 'OG002', 'title': 'DL 2B', 'description': 'alisertib tablets (60 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}, {'id': 'OG003', 'title': 'DL 3B', 'description': 'alisertib tablets (80 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}, {'id': 'OG004', 'title': 'Oral Solution', 'description': 'alisertib oral solution (45 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}], 'classes': [{'categories': [{'measurements': [{'value': '28.15', 'groupId': 'OG000', 'lowerLimit': '16.9', 'upperLimit': '65.5'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '15.4', 'upperLimit': '44.9'}, {'value': '30.71', 'groupId': 'OG002', 'lowerLimit': '19.61', 'upperLimit': '117.03'}, {'value': '47.73', 'groupId': 'OG003', 'lowerLimit': '32.71', 'upperLimit': '84.67'}, {'value': '58.15', 'groupId': 'OG004', 'lowerLimit': '32.03', 'upperLimit': '144.72'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1st week of cycle 1', 'description': 'Outcomes included Alisertib, irinotecan, APC, SN-38, and SN-38G. APC, SN-38, and SN-38G are metabolites of irinotecan.', 'unitOfMeasure': 'µM•hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics When Given Together With Fixed Doses of Irinotecan and Temozolomide in Children and Young Adults With Relapsed or Refractory Neuroblastoma: Irinotecan Cmax, APC Cmax, SN-38 Cmax, and SN-38G Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'DL 1', 'description': 'alisertib tablets (45 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis optional'}, {'id': 'OG001', 'title': 'DL 1B', 'description': 'alisertib tablets (45 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}, {'id': 'OG002', 'title': 'DL 2B', 'description': 'alisertib tablets (60 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}, {'id': 'OG003', 'title': 'DL 3B', 'description': 'alisertib tablets (80 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}, {'id': 'OG004', 'title': 'Ph 2', 'description': 'alisertib tablets (60 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}, {'id': 'OG005', 'title': 'Oral Solution', 'description': 'alisertib oral solution (45 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}], 'classes': [{'title': 'Irinotecan Cmax', 'categories': [{'measurements': [{'value': '722', 'groupId': 'OG000', 'lowerLimit': '502', 'upperLimit': '880'}, {'value': '703', 'groupId': 'OG001', 'lowerLimit': '642', 'upperLimit': '5,371'}, {'value': '1,238', 'groupId': 'OG002', 'lowerLimit': '493', 'upperLimit': '1,757'}, {'value': '784', 'groupId': 'OG003', 'lowerLimit': '546', 'upperLimit': '987'}, {'value': '881', 'groupId': 'OG004', 'lowerLimit': '490', 'upperLimit': '1,757'}, {'value': '732', 'groupId': 'OG005', 'lowerLimit': '422', 'upperLimit': '861'}]}]}, {'title': 'APC Cmax', 'categories': [{'measurements': [{'value': '61.2', 'groupId': 'OG000', 'lowerLimit': '23.1', 'upperLimit': '480.4'}, {'value': '59.8', 'groupId': 'OG001', 'lowerLimit': '28.2', 'upperLimit': '105'}, {'value': '55.8', 'groupId': 'OG002', 'lowerLimit': '25.7', 'upperLimit': '76.3'}, {'value': '43.4', 'groupId': 'OG003', 'lowerLimit': '29.1', 'upperLimit': '49.4'}, {'value': '57.1', 'groupId': 'OG004', 'lowerLimit': '25.7', 'upperLimit': '132'}, {'value': '51.4', 'groupId': 'OG005', 'lowerLimit': '15.0', 'upperLimit': '98.2'}]}]}, {'title': 'SN-38 Cmax', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '6.6', 'upperLimit': '18.7'}, {'value': '12.6', 'groupId': 'OG001', 'lowerLimit': '5.8', 'upperLimit': '16.5'}, {'value': '12.0', 'groupId': 'OG002', 'lowerLimit': '8.8', 'upperLimit': '14.7'}, {'value': '11.7', 'groupId': 'OG003', 'lowerLimit': '7.0', 'upperLimit': '13.8'}, {'value': '10.4', 'groupId': 'OG004', 'lowerLimit': '5.19', 'upperLimit': '32.6'}, {'value': '8.26', 'groupId': 'OG005', 'lowerLimit': '4.62', 'upperLimit': '33.1'}]}]}, {'title': 'SN-38G Cmax', 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000', 'lowerLimit': '16.0', 'upperLimit': '46.9'}, {'value': '16.9', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '23.7'}, {'value': '13.8', 'groupId': 'OG002', 'lowerLimit': '7.0', 'upperLimit': '26.8'}, {'value': '13.0', 'groupId': 'OG003', 'lowerLimit': '10.4', 'upperLimit': '24.0'}, {'value': '12.8', 'groupId': 'OG004', 'lowerLimit': '6.96', 'upperLimit': '50.5'}, {'value': '15.2', 'groupId': 'OG005', 'lowerLimit': '4.83', 'upperLimit': '46.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1st week of cycle 1', 'description': 'Outcomes included Alisertib, irinotecan, APC, SN-38, and SN-38G. APC, SN-38, and SN-38G are metabolites of irinotecan.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics When Given Together With Fixed Doses of Irinotecan and Temozolomide in Children and Young Adults With Relapsed or Refractory Neuroblastoma: Irinotecan AUC, APC AUC, SN-38 AUC, and SN-38G AUC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'DL 1', 'description': 'alisertib tablets (45 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis optional'}, {'id': 'OG001', 'title': 'DL 1B', 'description': 'alisertib tablets (45 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}, {'id': 'OG002', 'title': 'DL 2B', 'description': 'alisertib tablets (60 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}, {'id': 'OG003', 'title': 'DL 3B', 'description': 'alisertib tablets (80 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}, {'id': 'OG004', 'title': 'Ph 2', 'description': 'alisertib tablets (60 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}, {'id': 'OG005', 'title': 'Oral Solution', 'description': 'alisertib oral solution (45 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}], 'classes': [{'title': 'Irinotecan AUC', 'categories': [{'measurements': [{'value': '3,702', 'groupId': 'OG000', 'lowerLimit': '2,059', 'upperLimit': '5,772'}, {'value': '2,680', 'groupId': 'OG001', 'lowerLimit': '1,626', 'upperLimit': '8,492'}, {'value': '3,957', 'groupId': 'OG002', 'lowerLimit': '3,231', 'upperLimit': '4,301'}, {'value': '2,615', 'groupId': 'OG003', 'lowerLimit': '2,414', 'upperLimit': '3,288'}, {'value': '3,533', 'groupId': 'OG004', 'lowerLimit': '1,906', 'upperLimit': '4,301'}, {'value': '3,121', 'groupId': 'OG005', 'lowerLimit': '2,001', 'upperLimit': '7,970'}]}]}, {'title': 'APC AUC', 'categories': [{'measurements': [{'value': '571', 'groupId': 'OG000', 'lowerLimit': '248', 'upperLimit': '3,313'}, {'value': '477', 'groupId': 'OG001', 'lowerLimit': '197', 'upperLimit': '1,083'}, {'value': '511', 'groupId': 'OG002', 'lowerLimit': '293', 'upperLimit': '821'}, {'value': '418', 'groupId': 'OG003', 'lowerLimit': '299', 'upperLimit': '457'}, {'value': '511', 'groupId': 'OG004', 'lowerLimit': '293', 'upperLimit': '1,429'}, {'value': '616', 'groupId': 'OG005', 'lowerLimit': '221', 'upperLimit': '985'}]}]}, {'title': 'SN-38 AUC', 'categories': [{'measurements': [{'value': '63.2', 'groupId': 'OG000', 'lowerLimit': '20.5', 'upperLimit': '294.6'}, {'value': '52.9', 'groupId': 'OG001', 'lowerLimit': '28.4', 'upperLimit': '119.6'}, {'value': '80.8', 'groupId': 'OG002', 'lowerLimit': '35.0', 'upperLimit': '109.9'}, {'value': '72.0', 'groupId': 'OG003', 'lowerLimit': '62.6', 'upperLimit': '102.0'}, {'value': '90.0', 'groupId': 'OG004', 'lowerLimit': '35.0', 'upperLimit': '235'}, {'value': '56.7', 'groupId': 'OG005', 'lowerLimit': '26.2', 'upperLimit': '398'}]}]}, {'title': 'SN-38G AUC', 'categories': [{'measurements': [{'value': '206.5', 'groupId': 'OG000', 'lowerLimit': '124.3', 'upperLimit': '325.3'}, {'value': '97.6', 'groupId': 'OG001', 'lowerLimit': '53.8', 'upperLimit': '243.6'}, {'value': '141.8', 'groupId': 'OG002', 'lowerLimit': '77.5', 'upperLimit': '298.1'}, {'value': '134.4', 'groupId': 'OG003', 'lowerLimit': '101.1', 'upperLimit': '237.8'}, {'value': '132', 'groupId': 'OG004', 'lowerLimit': '71.0', 'upperLimit': '498'}, {'value': '136', 'groupId': 'OG005', 'lowerLimit': '74.6', 'upperLimit': '673'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1st week of cycle 1', 'description': 'Outcomes included Alisertib, irinotecan, APC, SN-38, and SN-38G. APC, SN-38, and SN-38G are metabolites of irinotecan.', 'unitOfMeasure': 'h·ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetics When Given Together With Fixed Doses of Irinotecan and Temozolomide in Children and Young Adults With Relapsed or Refractory Neuroblastoma: Irinotecan Clearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'DL 1', 'description': 'alisertib tablets (45 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis optional'}, {'id': 'OG001', 'title': 'DL 1B', 'description': 'alisertib tablets (45 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}, {'id': 'OG002', 'title': 'DL 2B', 'description': 'alisertib tablets (60 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}, {'id': 'OG003', 'title': 'DL 3B', 'description': 'alisertib tablets (80 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}, {'id': 'OG004', 'title': 'Ph 2', 'description': 'alisertib tablets (60 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}, {'id': 'OG005', 'title': 'Oral Solution', 'description': 'alisertib oral solution (45 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}], 'classes': [{'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000', 'lowerLimit': '8.8', 'upperLimit': '29.4'}, {'value': '15.7', 'groupId': 'OG001', 'lowerLimit': '4.6', 'upperLimit': '27.3'}, {'value': '10.4', 'groupId': 'OG002', 'lowerLimit': '9.0', 'upperLimit': '31.4'}, {'value': '16.0', 'groupId': 'OG003', 'lowerLimit': '12.6', 'upperLimit': '20.1'}, {'value': '12.6', 'groupId': 'OG004', 'lowerLimit': '7.65', 'upperLimit': '31.7'}, {'value': '10.3', 'groupId': 'OG005', 'lowerLimit': '4.12', 'upperLimit': '20.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1st week of cycle 1', 'description': 'Outcomes included Alisertib, irinotecan, APC, SN-38, and SN-38G. APC, SN-38, and SN-38G are metabolites of irinotecan.', 'unitOfMeasure': 'L/h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Response Rate for Patients With Relapsed or Refractory Neuroblastoma Treated With MLN8237, Irinotecan, and Temozolomide at the Identified MTD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ph 2', 'description': 'alisertib tablets (60 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}], 'classes': [{'title': 'Complete Response (CR)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'CR-Minimal Residual Disease (MRD)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Partial Response (PR)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Minor Response', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Stable Disease', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Progressive Disease', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Response Rate (CR + CR-MRD + PR)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Cycles repeated every 21 days for up to 34 cycles.', 'description': 'Response was graded according to version 1.2 of the NANT response criteria that classifies patients as having one of the following overall response categories based upon underlying response at soft tissue sites, MIBG positive sites, and bone marrow disease: complete response (CR); CR with minimal residual disease (CR-MRD); partial response (PR); minor response (MR); stable disease (SD); and progressive disease (PD). These criteria utilize RECIST criteria for measurable tumors, Curie score for MIBG scan response, and bone marrow (BM) morphology. BM response was graded as CR (required two time points to confirm), CR unconfirmed (one time point only), CR-MRD (bone marrow involvement \\< 5% at study entry with negative follow-up biopsies), SD, or PD. Patients with at least SD or better underwent central review of MIBG scans, CT scans, and bone marrow pathology slides. Overall responses of CR, CR-MRD, or PR were considered objective responses.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on 19 phase II patients, with 1 inevaluable patient excluded.'}, {'type': 'SECONDARY', 'title': 'Aurora A Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Objective Responders', 'description': 'Consisting of complete response (CR), CR with minimal residual disease (CR-MRD), and partial response (PR).'}, {'id': 'OG001', 'title': 'Objective Non-Responders', 'description': 'Consisting of minor response (MR), stable disease (SD) and progressive disease (PD).'}], 'classes': [{'title': 'MYCN Amplified', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'MYCN not Amplified', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'MYCN Missing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'MYCN Amplified or Myc Positive', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'MYCN Non-amplified and Myc Negative', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'MYCN or Myc Missing', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Aurora A protein Positive', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Aurora A protein Negative', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Aurora A protein Missing', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.14', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'MYCN Amplified vs. MYCN not Amplified', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.21', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'MYCN Amplified or Myc Positive vs. MYCN Non-amplified and Myc Negative'}, {'pValue': '1.0', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Aurora A protein Positive vs. Aurora A protein Negative'}], 'paramType': 'NUMBER', 'timeFrame': 'From date of study enrollment to the date of progression or withdrawal from the study, up to 34 cycles (about 2 years).', 'description': 'To explore whether MYCN status and markers of expression of Aurora A in archival tumor tissue are associated with the antitumor activity of the combination of MLN8237, irinotecan, and temozolomide', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Consisting of patients treated on the Phase 1 (n = 22), Phase 2 (n = 20), and Oral Solution (n = 12) cohorts.'}, {'type': 'SECONDARY', 'title': 'UGT1A1 Genotype', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'First Cycle DLT Yes', 'description': 'Patients who had DLT in the first cycle of treatment.'}, {'id': 'OG001', 'title': 'First Cycle DLT No', 'description': 'Patients who did not have DLT in the first cycle of treatment.'}, {'id': 'OG002', 'title': 'DLT in Any Cycle Yes', 'description': 'Patients who had DLT in any cycle of treatment.'}, {'id': 'OG003', 'title': 'DLT in Any Cycle No', 'description': 'Patients who did not have DLT in any cycle of treatment.'}], 'classes': [{'title': 'UGT1A1 6\\6', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'UGT1A1 6\\7', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'UGT1A1 7\\7', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'UGT1A1 Missing', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.094', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'UGT1A1 6\\\\6 vs. UGT1A1 6\\\\7 vs. UGT1A1 7\\\\7', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.63', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'UGT1A1 6\\\\6 vs. UGT1A1 6\\\\7 vs. UGT1A1 7\\\\7', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 7 of cycle 1', 'description': 'To explore whether UGT1A1 genotype is associated with toxicity in children with refractory neuroblastoma treated with the combination of MLN8237, irinotecan, and temozolomide', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Consisting of patients treated on the Phase 1 (n = 22), Phase 2 (n = 20), and Oral Solution (n = 12) cohorts.'}, {'type': 'SECONDARY', 'title': 'AURKA Genotype', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Objective Responders', 'description': 'Consisting of complete response (CR), CR with minimal residual disease (CR-MRD), and partial response (PR).'}, {'id': 'OG001', 'title': 'Objective Non-Responders', 'description': 'Consisting of minor response (MR), stable disease (SD) and progressive disease (PD).'}], 'classes': [{'title': 'AurkA Codon 31 Summary H', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'AurkA Codon 31 Summary V', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'AurkA Codon 31 Summary W', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'AurkA Codon 31 Summary Missing', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'AurkA Codon 57 Summary H', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'AurkA Codon 57 Summary W', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'AurkA Codon 57 Summary Missing', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.90', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'AurkA Codon 31 Summary H vs. AurkA Codon 31 Summary V vs. AurkA Codon 31 Summary W', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}, {'pValue': '1.0', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'AurkA Codon 57 Summary H vs. AurkA Codon 57 Summary W', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 7 of cycle 1', 'description': 'To explore whether AURKA genotype is associated with antitumor activity in children with refractory neuroblastoma treated with the combination of MLN8237, irinotecan, and temozolomide.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Consisting of patients treated on the Phase 1 (n = 22), Phase 2 (n = 20), and Oral Solution (n = 12) cohorts.'}, {'type': 'SECONDARY', 'title': 'One Year Progression Free Survival Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ph 2', 'description': 'alisertib tablets (60 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 Years after completion of study', 'description': 'To determine the progression free survival rates for patients with relapsed or refractory neuroblastoma treated with MLN8237, irinotecan, and temozolomide at the identified MTD', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed in phase II patients.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DL 1', 'description': 'alisertib tablets (45 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis optional'}, {'id': 'FG001', 'title': 'DL 1B', 'description': 'alisertib tablets (45 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}, {'id': 'FG002', 'title': 'DL 2B', 'description': 'alisertib tablets (60 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}, {'id': 'FG003', 'title': 'DL 3B', 'description': 'alisertib tablets (80 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}, {'id': 'FG004', 'title': 'Ph 2', 'description': 'alisertib tablets (60 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}, {'id': 'FG005', 'title': 'Oral Solution', 'description': 'alisertib oral solution (45 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}], 'periods': [{'title': 'Phase 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Started Another Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Phase 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '20'}, {'groupId': 'FG005', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '19'}, {'groupId': 'FG005', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'Started Another Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '54', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'DL 1', 'description': 'alisertib tablets (45 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis optional'}, {'id': 'BG001', 'title': 'DL 1B', 'description': 'alisertib tablets (45 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}, {'id': 'BG002', 'title': 'DL 2B', 'description': 'alisertib tablets (60 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}, {'id': 'BG003', 'title': 'DL 3B', 'description': 'alisertib tablets (80 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}, {'id': 'BG004', 'title': 'Ph 2', 'description': 'alisertib tablets (60 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}, {'id': 'BG005', 'title': 'Oral Solution', 'description': 'alisertib oral solution (45 mg/m\\^2/dose x 7 days), irinotecan (50 mg/m\\^2/dose IV x 5 days), temozolomide (100 mg/m\\^2/dose orally x 5 days), myeloid growth factor support and cephalosporin diarrhea prophylaxis required'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8.60', 'groupId': 'BG000', 'lowerLimit': '7.39', 'upperLimit': '18.53'}, {'value': '6.81', 'groupId': 'BG001', 'lowerLimit': '4.70', 'upperLimit': '13.26'}, {'value': '7.67', 'groupId': 'BG002', 'lowerLimit': '4.34', 'upperLimit': '22.74'}, {'value': '6.14', 'groupId': 'BG003', 'lowerLimit': '4.66', 'upperLimit': '12.66'}, {'value': '10.74', 'groupId': 'BG004', 'lowerLimit': '4.36', 'upperLimit': '19.42'}, {'value': '3.05', 'groupId': 'BG005', 'lowerLimit': '1.69', 'upperLimit': '7.20'}, {'value': '7.61', 'groupId': 'BG006', 'lowerLimit': '1.69', 'upperLimit': '22.74'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '38', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}, {'title': 'Not Hispanic Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}]}]}, {'title': 'Not Hispanic White', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '45', 'groupId': 'BG006'}]}]}, {'title': 'Not Hispanic Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}, {'title': 'Not Hispanic Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '54', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Prior Irinotecan', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '18', 'groupId': 'BG006'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '36', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior Temozolomide', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '37', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-10', 'size': 1297905, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2019-05-30T20:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-10', 'studyFirstSubmitDate': '2012-05-11', 'resultsFirstSubmitDate': '2019-05-30', 'studyFirstSubmitQcDate': '2012-05-16', 'lastUpdatePostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-10', 'studyFirstPostDateStruct': {'date': '2012-05-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD) When Given Together With Fixed Doses of Irinotecan and Temozolomide in Children and Young Adults With Relapsed or Refractory Neuroblastoma', 'timeFrame': '21 days, from study day 1', 'description': 'The MTD was the highest dose level tested at which fewer than two of six patients had first course DLT. Hematologic DLT was defined as grade 4 neutropenia for more than 7 days, need for platelet transfusion for a platelet count of less than 20,000/mL twice within a 7-day period, or greater than 14-day delay in the start of a subsequent course because of neutropenia or thrombocytopenia. Nonhematologic DLT was defined as any nonhematologic toxicity that delayed the start of a subsequent cycle by more than 14 days or any grade ≥3 toxicity with the exception of the following grade 3 toxicities: nausea, vomiting, anorexia, or dehydration resolving to grade ≤ 2 within 72 hours; increase in hepatic transaminase or electrolyte abnormality resolving to grade ≤ 1 within 7 days; diarrhea persisting for less than 72 hours; fever; infection; or febrile neutropenia. DLT definitions included only toxicities deemed at least possibly related to therapy.'}, {'measure': 'Dose Limiting Toxicity (DLT) Data Associated With the Determination of the Recommended Phase 2 Dose', 'timeFrame': '21 days, from study day 1', 'description': 'The MTD was the highest dose level tested at which fewer than two of six patients had first course DLT. Hematologic DLT was defined as grade 4 neutropenia for more than 7 days, need for platelet transfusion for a platelet count of less than 20,000/mL twice within a 7-day period, or greater than 14-day delay in the start of a subsequent course because of neutropenia or thrombocytopenia. Nonhematologic DLT was defined as any nonhematologic toxicity that delayed the start of a subsequent cycle by more than 14 days or any grade ≥3 toxicity with the exception of the following grade 3 toxicities: nausea, vomiting, anorexia, or dehydration resolving to grade ≤ 2 within 72 hours; increase in hepatic transaminase or electrolyte abnormality resolving to grade ≤ 1 within 7 days; diarrhea persisting for less than 72 hours; fever; infection; or febrile neutropenia. DLT definitions included only toxicities deemed at least possibly related to therapy.'}, {'measure': 'Pharmacokinetics When Given Together With Fixed Doses of Irinotecan and Temozolomide in Children and Young Adults With Relapsed or Refractory Neuroblastoma: Alisertib Day 4 Trough, Day 5 Trough and Cmax', 'timeFrame': '1st week of cycle 1', 'description': 'Outcomes included Alisertib, irinotecan, APC, SN-38, and SN-38G. APC, SN-38, and SN-38G are metabolites of irinotecan.'}, {'measure': 'Pharmacokinetics When Given Together With Fixed Doses of Irinotecan and Temozolomide in Children and Young Adults With Relapsed or Refractory Neuroblastoma: Alisertib Tmax and Half-life', 'timeFrame': '1st week of cycle 1', 'description': 'Outcomes included Alisertib, irinotecan, APC, SN-38, and SN-38G. APC, SN-38, and SN-38G are metabolites of irinotecan.'}, {'measure': 'Pharmacokinetics When Given Together With Fixed Doses of Irinotecan and Temozolomide in Children and Young Adults With Relapsed or Refractory Neuroblastoma: Alisertib AUC', 'timeFrame': '1st week of cycle 1', 'description': 'Outcomes included Alisertib, irinotecan, APC, SN-38, and SN-38G. APC, SN-38, and SN-38G are metabolites of irinotecan.'}, {'measure': 'Pharmacokinetics When Given Together With Fixed Doses of Irinotecan and Temozolomide in Children and Young Adults With Relapsed or Refractory Neuroblastoma: Irinotecan Cmax, APC Cmax, SN-38 Cmax, and SN-38G Cmax', 'timeFrame': '1st week of cycle 1', 'description': 'Outcomes included Alisertib, irinotecan, APC, SN-38, and SN-38G. APC, SN-38, and SN-38G are metabolites of irinotecan.'}, {'measure': 'Pharmacokinetics When Given Together With Fixed Doses of Irinotecan and Temozolomide in Children and Young Adults With Relapsed or Refractory Neuroblastoma: Irinotecan AUC, APC AUC, SN-38 AUC, and SN-38G AUC', 'timeFrame': '1st week of cycle 1', 'description': 'Outcomes included Alisertib, irinotecan, APC, SN-38, and SN-38G. APC, SN-38, and SN-38G are metabolites of irinotecan.'}, {'measure': 'Pharmacokinetics When Given Together With Fixed Doses of Irinotecan and Temozolomide in Children and Young Adults With Relapsed or Refractory Neuroblastoma: Irinotecan Clearance', 'timeFrame': '1st week of cycle 1', 'description': 'Outcomes included Alisertib, irinotecan, APC, SN-38, and SN-38G. APC, SN-38, and SN-38G are metabolites of irinotecan.'}, {'measure': 'Response Rate for Patients With Relapsed or Refractory Neuroblastoma Treated With MLN8237, Irinotecan, and Temozolomide at the Identified MTD', 'timeFrame': 'Cycles repeated every 21 days for up to 34 cycles.', 'description': 'Response was graded according to version 1.2 of the NANT response criteria that classifies patients as having one of the following overall response categories based upon underlying response at soft tissue sites, MIBG positive sites, and bone marrow disease: complete response (CR); CR with minimal residual disease (CR-MRD); partial response (PR); minor response (MR); stable disease (SD); and progressive disease (PD). These criteria utilize RECIST criteria for measurable tumors, Curie score for MIBG scan response, and bone marrow (BM) morphology. BM response was graded as CR (required two time points to confirm), CR unconfirmed (one time point only), CR-MRD (bone marrow involvement \\< 5% at study entry with negative follow-up biopsies), SD, or PD. Patients with at least SD or better underwent central review of MIBG scans, CT scans, and bone marrow pathology slides. Overall responses of CR, CR-MRD, or PR were considered objective responses.'}], 'secondaryOutcomes': [{'measure': 'Aurora A Expression', 'timeFrame': 'From date of study enrollment to the date of progression or withdrawal from the study, up to 34 cycles (about 2 years).', 'description': 'To explore whether MYCN status and markers of expression of Aurora A in archival tumor tissue are associated with the antitumor activity of the combination of MLN8237, irinotecan, and temozolomide'}, {'measure': 'UGT1A1 Genotype', 'timeFrame': 'Day 7 of cycle 1', 'description': 'To explore whether UGT1A1 genotype is associated with toxicity in children with refractory neuroblastoma treated with the combination of MLN8237, irinotecan, and temozolomide'}, {'measure': 'AURKA Genotype', 'timeFrame': 'Day 7 of cycle 1', 'description': 'To explore whether AURKA genotype is associated with antitumor activity in children with refractory neuroblastoma treated with the combination of MLN8237, irinotecan, and temozolomide.'}, {'measure': 'One Year Progression Free Survival Rate', 'timeFrame': '1 Years after completion of study', 'description': 'To determine the progression free survival rates for patients with relapsed or refractory neuroblastoma treated with MLN8237, irinotecan, and temozolomide at the identified MTD'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Neuroblastoma']}, 'referencesModule': {'references': [{'pmid': '30093449', 'type': 'DERIVED', 'citation': 'DuBois SG, Mosse YP, Fox E, Kudgus RA, Reid JM, McGovern R, Groshen S, Bagatell R, Maris JM, Twist CJ, Goldsmith K, Granger MM, Weiss B, Park JR, Macy ME, Cohn SL, Yanik G, Wagner LM, Hawkins R, Courtier J, Lai H, Goodarzian F, Shimada H, Boucher N, Czarnecki S, Luo C, Tsao-Wei D, Matthay KK, Marachelian A. Phase II Trial of Alisertib in Combination with Irinotecan and Temozolomide for Patients with Relapsed or Refractory Neuroblastoma. Clin Cancer Res. 2018 Dec 15;24(24):6142-6149. doi: 10.1158/1078-0432.CCR-18-1381. Epub 2018 Aug 9.'}]}, 'descriptionModule': {'briefSummary': 'The goal of the first part of this clinical trial (Phase I portion) is to study the side effects, drug breakdown (pharmacokinetics), and dosing of the drug MLN8237 when added to standard chemotherapy drugs, irinotecan and temozolomide.\n\nThe goal of the second part of this clinical trial (Phase II portion) is to learn how many children and young adults show improvements in their neuroblastoma when treated with the combination of MLN8237, irinotecan, and temozolomide.', 'detailedDescription': 'The Aurora A kinase has been shown to play an important role in neuroblastoma growth. Inhibition of Aurora A kinase activity attenuates the growth of neuroblastoma cells. MLN8237 is a selective small molecule inhibitor of Aurora A kinase that has completed pediatric single-agent phase I testing, as well as stage 1 phase 2 testing in patients with Neuroblastoma. MLN8237 showed activity against the NCI-sponsored Pediatric Preclinical Testing Program neuroblastoma in vivo panel that exceeded the activity level observed with chemotherapy agents routinely used in the treatment of neuroblastoma. Additional in vitro and in vivo studies have shown that Aurora A kinase inhibitors result in enhanced cytotoxicity when used in combination with chemotherapy. Irinotecan and temozolomide is a commonly used salvage regimen for patients with relapsed or refractory neuroblastoma. This combination has a modest objective response rate (16%) and is well-tolerated, suggesting that it will provide a useful platform for the study of novel compounds in combination with chemotherapy. Preclinical studies demonstrate marked enhancement of anti-neuroblastoma activity with the addition of MLN8237 to irinotecan and temozolomide. This study therefore evaluates the tolerability and activity of MLN8237 in combination with irinotecan and temozolomide in children with refractory or relapsed neuroblastoma. Patients receive irinotecan (50 mg/m2/dose IV) and temozolomide (100 mg/m2/dose orally) once daily for 5 days along with MLN8237 orally once daily for 7 days. The doses of irinotecan and temozolomide will be fixed and the dose of MLN8237 will be dose-escalated. In the phase I portion of the study, the primary aims are to determine the recommended phase II doses of this combination, describe the toxicity of this combination, and characterize the pharmacokinetic profile of MLN8237 and irinotecan when used in combination. In the phase II portion of the study, the primary aim is to determine the objective response rate of this combination in patients with relapsed or refractory neuroblastoma. With Amendment 5, the tolerability and pharmacokinetics of an MLN8237 oral solution will be evaluated. Optional correlative studies will evaluate UGT1A1 polymorphisms as predictors of toxicity and archival tumor tissue Aurora A expression as a predictor of response with this combination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '12 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Criteria that need to be met to participate in this study:\n\n* Patients must be \\> 12 months and \\< 30 years of age when registered on study.\n* Patients must have relapsed neuroblastoma, refractory neuroblastoma that had less than a partial response to standard treatment or persistent neuroblastoma that had at least a partial response to standard treatment. All patients must have at least ONE site of evaluable disease.\n\n o Patients who have at least a partial response to standard treatment who still have neuroblastoma that can be seen on CT/MRI or MIBG scans must have a surgical biopsy done of the tumor to confirm that it is neuroblastoma. Patients with relapsed or refractory neuroblastoma do not need to have a biopsy done to enter on study.\n* Patients must have adequate heart, kidney, liver and bone marrow function. Patients who have bone marrow disease must still have adequate bone marrow function to enter the study.\n* MLN8237 must be swallowed as whole tablets. Therefore, patients must be able to swallow pills to be eligible for study. One tablet is the size of small breath mint, or baby aspirin. Due to the size of MLN8237 tablets, patients must have a body surface area of at least 0.38 m2 to be eligible for study. A body surface area is a combination of a patient's height and weight. An example of a child with a BSA of 0.45 is a child that is 25 inches tall and weighs 25 pounds.You can use the link below to calculate your child's body surface area and determine if they are too small for this trial.\n\nPatients cannot participate in the study if:\n\n* Patients who have received prior MLN8237 are excluded from all phases of the study. Patients previously treated with irinotecan and/or temozolomide will be eligible if they have not had documented progressive disease during treatment with a regimen containing these agents.\n* They have other medical problems that could get much worse if they had this treatment.\n* They are on dialysis for bad kidney function.\n* They are pregnant or breast feeding.\n* They have active infections such as hepatitis or fungal infections.\n* They have an allergy to treatment with cefixime and cefpodixime.\n* They have brain metastasis at study entry, or have received cranial spinal radiation.\n* They have had an allogeneic stem cell transplant (received stem cell from someone else).\n* They can't cooperate with the special precautions that are needed for this trial."}, 'identificationModule': {'nctId': 'NCT01601535', 'briefTitle': 'Study of MLN8237 in Combination With Irinotecan and Temozolomide', 'organization': {'class': 'OTHER', 'fullName': 'New Approaches to Neuroblastoma Therapy Consortium'}, 'officialTitle': 'Phase I/II Study of MLN8237 in Combination With Irinotecan and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma', 'orgStudyIdInfo': {'id': 'N2009-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Every course will be 21 days. MLN8237 will be administered orally daily starting on day 1 through day 7.\n\nIrinotecan will be administered intravenously during each course on study day 1 through day 5.\n\nTemozolomide will be administered orally during each course on study day 1 through day 5.', 'interventionNames': ['Drug: MLN8237', 'Drug: Irinotecan', 'Drug: Temozolomide']}], 'interventions': [{'name': 'MLN8237', 'type': 'DRUG', 'description': 'Every course will be 21 days. MLN8237 will be administered orally daily starting on day 1 through day 7.', 'armGroupLabels': ['Treatment']}, {'name': 'Irinotecan', 'type': 'DRUG', 'otherNames': ['Camptosar'], 'description': 'Irinotecan will be administered intravenously during each course on study day 1 through day 5.', 'armGroupLabels': ['Treatment']}, {'name': 'Temozolomide', 'type': 'DRUG', 'otherNames': ['Temodar'], 'description': 'Temozolomide will be administered orally during each course on study day 1 through day 5.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027-0700', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's 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': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Helen Diller Family Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Children Hospital of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta", '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': 'Childrens Hospital Boston, Dana-Farber Cancer Institute.', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Comprehensive Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'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': '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': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Steven DuBois, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New Approaches to Neuroblastoma Therapy Consortium', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}