Ignite Creation Date:
2025-12-24 @ 9:29 PM
Ignite Modification Date:
2026-04-08 @ 5:54 PM
Study NCT ID:
NCT02095132
Status:
COMPLETED
Last Update Posted:
2023-09-26
First Post:
2014-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Adavosertib and Irinotecan Hydrochloride in Treating Younger Patients With Relapsed or Refractory Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D010871', 'term': 'Pinealoma'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D008527', 'term': 'Medulloblastoma'}, {'id': 'D009447', 'term': 'Neuroblastoma'}, {'id': 'D012208', 'term': 'Rhabdomyosarcoma'}], 'ancestors': [{'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'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}, {'id': 'D009217', 'term': 'Myosarcoma'}, {'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D012509', 'term': 'Sarcoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C549567', 'term': 'adavosertib'}, {'id': 'D000077146', 'term': 'Irinotecan'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'resultsreportingcoordinator@childrensoncologygroup.org', 'phone': '626-447-0064', 'title': 'Results Reporting Coordinator', 'organization': "Children's Oncology Group"}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 12 months', 'description': 'Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Part A, Dose Level 1', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 70 mg/m2 Irinotecan (IRIN) and 50 mg/m2 AZD1775 (MK-1775)', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 1, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Part A, Dose Level 2', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 70 mg/m2 Irinotecan (IRIN) and 65 mg/m2 AZD1775 (MK-1775)', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Part A, Dose Level 3', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 90 mg/m2 Irinotecan (IRIN) and 65 mg/m2 AZD1775 (MK-1775)', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Part A, Dose Level 4', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 90 mg/m2 Irinotecan (IRIN) and 85 mg/m2 AZD1775 (MK-1775)', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 10}, {'id': 'EG004', 'title': 'Part A, Dose Level 5', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 90 mg/m2 Irinotecan (IRIN) and 110 mg/m2 AZD1775 (MK-1775)', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG005', 'title': 'Part A, PK Expansion', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at the MTD/RP2D of 90 mg/m2 Irinotecan (IRIN) and 110 mg/m2 AZD1775 (MK-1775)', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG006', 'title': 'Part B, Neuroblastoma', 'description': 'Patients with relapsed or refractory neuroblastoma treated at the MTD/RP2D of 90 mg/m2 Irinotecan (IRIN) and 85 mg/m2 AZD1775 (MK-1775)', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 19, 'seriousNumAtRisk': 19, 'deathsNumAffected': 1, 'seriousNumAffected': 11}, {'id': 'EG007', 'title': 'Part C, Medulloblastoma/CNS PNET', 'description': 'Patients with relapsed or refractory Medulloblastoma/CNS PNET treated at the MTD/RP2D of 90 mg/m2 Irinotecan (IRIN) and 85 mg/m2 AZD1775 (MK-1775)', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 1, 'seriousNumAffected': 9}, {'id': 'EG008', 'title': 'Part D, Rhabdomyosarcoma', 'description': 'Patients with relapsed or refractory Rhabdomyosarcoma treated at the MTD/RP2D of 90 mg/m2 Irinotecan (IRIN) and 85 mg/m2 AZD1775 (MK-1775)', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 1, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abducens nerve disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acoustic nerve disorder NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Activated partial thromboplastin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 10}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 8}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alkalosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 14}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 8}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 10}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 7}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG006', 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'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rectal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory, thoracic and mediastinal disorders - Other, BRADYPNEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory, thoracic and mediastinal disorders - Other, UPPER AIRWAY OBSTRUCTION -BULBAR IN NATURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin and subcutaneous tissue disorders - Other, TUMOR BLEEDING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stridor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgical and medical procedures - Other, BILATERAL LUNG WEDGE RESECTIONS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgical and medical procedures - Other, CYST DECOMPRESSION SURGERY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgical and medical procedures - Other, VENTRICULOPERITONEAL SHUNT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tumor pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urine output decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 19, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Tolerated Dose (MTD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A', 'description': 'Part A Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated with Irinotecan (IRIN) and AZD1775 (MK-1775)'}], 'classes': [{'title': 'Irinotecan (IRIN)', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}, {'title': 'AZD1775 (MK-1775)', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 21 days', 'description': 'MTD is defined as the maximum doses of adavosertib and irinotecan hydrochloride at which fewer than one-third of patients experience dose limiting toxicities when receiving this combination.', 'unitOfMeasure': 'mg/m^2', 'reportingStatus': 'POSTED', 'populationDescription': 'All Part A patients contributed to determining MTD. Only Toxicity evaluable patients were accounted.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Cycle 1 DLT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, Dose Level 1', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 70 mg/m2 Irinotecan (IRIN) and 50 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG001', 'title': 'Part A, Dose Level 2', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 70 mg/m2 Irinotecan (IRIN) and 65 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG002', 'title': 'Part A, Dose Level 3', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 90 mg/m2 Irinotecan (IRIN) and 65 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG003', 'title': 'Part A, Dose Level 4', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 90 mg/m2 Irinotecan (IRIN) and 85 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG004', 'title': 'Part A, Dose Level 5', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 90 mg/m2 Irinotecan (IRIN) and 110 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG005', 'title': 'Part A, PK Expansion', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at the MTD/RP2D of 90 mg/m2 Irinotecan (IRIN) and 110 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG006', 'title': 'Part B, Neuroblastoma', 'description': 'Patients with relapsed or refractory neuroblastoma treated at the MTD/RP2D of 90 mg/m2 Irinotecan (IRIN) and 85 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG007', 'title': 'Part C, Medulloblastoma/CNS PNET', 'description': 'Patients with relapsed or refractory Medulloblastoma/CNS PNET treated at the MTD/RP2D of 90 mg/m2 Irinotecan (IRIN) and 85 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG008', 'title': 'Part D, Rhabdomyosarcoma', 'description': 'Patients with relapsed or refractory Rhabdomyosarcoma treated at the MTD/RP2D of 90 mg/m2 Irinotecan (IRIN) and 85 mg/m2 AZD1775 (MK-1775)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 21 days', 'description': 'To define and describe the toxicities of AZD1755 (MK-1775) in combination with oral irinotecan administered on this schedule.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetic (PK) Parameters of Adavosertib in Terms of Systemic Exposure, AUC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, Dose Level 1', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 70 mg/m2 Irinotecan (IRIN) and 50 mg/m2 AZD1775 (MK-1775'}, {'id': 'OG001', 'title': 'Part A, Dose Level 2', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 70 mg/m2 Irinotecan (IRIN) and 65 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG002', 'title': 'Part A, Dose Level 3', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 90 mg/m2 Irinotecan (IRIN) and 65 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG003', 'title': 'Part A, Dose Level 4', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 90 mg/m2 Irinotecan (IRIN) and 85 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG004', 'title': 'Part A, Dose Level 5', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 90 mg/m2 Irinotecan (IRIN) and 110 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG005', 'title': 'Part A, PK Expansion', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at the MTD/RP2D of 90 mg/m2 Irinotecan (IRIN) and 110 mg/m2 AZD1775 (MK-1775)'}], 'classes': [{'categories': [{'measurements': [{'value': '3222.95', 'spread': '1770.92', 'groupId': 'OG000'}, {'value': '3397.3', 'spread': '2404.13', 'groupId': 'OG001'}, {'value': '4413.22', 'spread': '2026.63', 'groupId': 'OG002'}, {'value': '5344.96', 'spread': '1839.62', 'groupId': 'OG003'}, {'value': '5161.36', 'spread': '3282.31', 'groupId': 'OG004'}, {'value': '4655.13', 'spread': '1943.68', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 day 1 prior to the irinotecan infusion, prior to the adavosertib dose, 4 hours after the dose of adavosertib is given, and prior to the irinotecan dose on day 2', 'description': 'The PK parameters will be summarized by means and standard deviations', 'unitOfMeasure': 'hr*nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Summary statistics for PK parameter for patients in Part A. Per study protocol, PK measures were not required for Parts B, C, or D, therefore, data were not and will not be collected.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetic (PK) Parameters of Adavosertib in Terms of Systemic Exposure, Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, Dose Level 1', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 70 mg/m2 Irinotecan (IRIN) and 50 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG001', 'title': 'Part A, Dose Level 2', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 70 mg/m2 Irinotecan (IRIN) and 65 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG002', 'title': 'Part A, Dose Level 3', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 90 mg/m2 Irinotecan (IRIN) and 65 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG003', 'title': 'Part A, Dose Level 4', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 90 mg/m2 Irinotecan (IRIN) and 85 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG004', 'title': 'Part A, Dose Level 5', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 90 mg/m2 Irinotecan (IRIN) and 110 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG005', 'title': 'Part A, PK Expansion', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at the MTD/RP2D of 90 mg/m2 Irinotecan (IRIN) and 110 mg/m2 AZD1775 (MK-1775)'}], 'classes': [{'categories': [{'measurements': [{'value': '443.96', 'spread': '168.13', 'groupId': 'OG000'}, {'value': '511.23', 'spread': '341.4', 'groupId': 'OG001'}, {'value': '539.84', 'spread': '265.58', 'groupId': 'OG002'}, {'value': '652.71', 'spread': '240.27', 'groupId': 'OG003'}, {'value': '733.59', 'spread': '397.41', 'groupId': 'OG004'}, {'value': '590.28', 'spread': '378.65', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 day 1 prior to the irinotecan infusion, prior to the adavosertib dose, 4 hours after the dose of adavosertib is given, and prior to the irinotecan dose on day 2', 'description': 'The PK parameters will be summarized by means and standard deviations', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Summary statistics for PK parameter for patients in Part A. Per study protocol, PK measures were not required for Parts B, C, or D, therefore, data were not and will not be collected.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetic (PK) Parameters of Adavosertib in Terms of Systemic Exposure, HL-Lambda (Half Life)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, Dose Level 1', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 70 mg/m2 Irinotecan (IRIN) and 50 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG001', 'title': 'Part A, Dose Level 2', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 70 mg/m2 Irinotecan (IRIN) and 65 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG002', 'title': 'Part A, Dose Level 3', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 90 mg/m2 Irinotecan (IRIN) and 65 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG003', 'title': 'Part A, Dose Level 4', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 90 mg/m2 Irinotecan (IRIN) and 85 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG004', 'title': 'Part A, Dose Level 5', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 90 mg/m2 Irinotecan (IRIN) and 110 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG005', 'title': 'Part A, PK Expansion', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at the MTD/RP2D of 90 mg/m2 Irinotecan (IRIN) and 110 mg/m2 AZD1775 (MK-1775)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'spread': '1', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '3.9', 'groupId': 'OG001'}, {'value': '5.7', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '4.9', 'spread': '1', 'groupId': 'OG003'}, {'value': '4', 'spread': '2.1', 'groupId': 'OG004'}, {'value': '4.7', 'spread': '0.6', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 day 1 prior to the irinotecan infusion, prior to the adavosertib dose, 4 hours after the dose of adavosertib is given, and prior to the irinotecan dose on day 2', 'description': 'The PK parameters will be summarized by means and standard deviations', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Summary statistics for PK parameter for patients in Part A. Per study protocol, PK measures were not required for Parts B, C, or D, therefore, data were not and will not be collected.'}, {'type': 'PRIMARY', 'title': 'Pharmacokinetic (PK) Parameters of Adavosertib in Terms of Systemic Exposure, Tmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, Dose Level 1', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 70 mg/m2 Irinotecan (IRIN) and 50 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG001', 'title': 'Part A, Dose Level 2', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 70 mg/m2 Irinotecan (IRIN) and 65 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG002', 'title': 'Part A, Dose Level 3', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 90 mg/m2 Irinotecan (IRIN) and 65 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG003', 'title': 'Part A, Dose Level 4', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 90 mg/m2 Irinotecan (IRIN) and 85 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG004', 'title': 'Part A, Dose Level 5', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 90 mg/m2 Irinotecan (IRIN) and 110 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG005', 'title': 'Part A, PK Expansion', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at the MTD/RP2D of 90 mg/m2 Irinotecan (IRIN) and 110 mg/m2 AZD1775 (MK-1775)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '3', 'groupId': 'OG000'}, {'value': '2', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '3', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '3', 'spread': '1.1', 'groupId': 'OG003'}, {'value': '2.4', 'spread': '0.9', 'groupId': 'OG004'}, {'value': '3.5', 'spread': '3', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 day 1 prior to the irinotecan infusion, prior to the adavosertib dose, 4 hours after the dose of adavosertib is given, and prior to the irinotecan dose on day 2', 'description': 'The PK parameters will be summarized by means and standard deviations', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Summary statistics for PK parameter for patients in Part A. Per study protocol, PK measures were not required for Parts B, C, or D, therefore, data were not and will not be collected.'}, {'type': 'SECONDARY', 'title': 'Number and Percentage of Participants With Best Overall Response With Partial or Complete Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '19', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '10', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, Dose Level 1', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 70 mg/m2 Irinotecan (IRIN) and 50 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG001', 'title': 'Part A, Dose Level 2', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 70 mg/m2 Irinotecan (IRIN) and 65 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG002', 'title': 'Part A, Dose Level 3', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 90 mg/m2 Irinotecan (IRIN) and 65 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG003', 'title': 'Part A, Dose Level 4', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 90 mg/m2 Irinotecan (IRIN) and 85 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG004', 'title': 'Part A, Dose Level 5', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 90 mg/m2 Irinotecan (IRIN) and 110 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG005', 'title': 'Part A, PK Expansion', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at the MTD/RP2D of 90 mg/m2 Irinotecan (IRIN) and 110 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG006', 'title': 'Part B, Neuroblastoma', 'description': 'Patients with relapsed or refractory neuroblastoma treated at the MTD/RP2D of 90 mg/m2 Irinotecan (IRIN) and 85 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG007', 'title': 'Part C, Medulloblastoma/CNS PNET', 'description': 'Patients with relapsed or refractory Medulloblastoma/CNS PNET treated at the MTD/RP2D of 90 mg/m2 Irinotecan (IRIN) and 85 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG008', 'title': 'Part D, Rhabdomyosarcoma', 'description': 'Patients with relapsed or refractory Rhabdomyosarcoma treated at the MTD/RP2D of 90 mg/m2 Irinotecan (IRIN) and 85 mg/m2 AZD1775 (MK-1775)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 1 year', 'description': 'Frequency (%) of response-evaluable patients with best overall response of partial or complete response as determined by revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with complete response or partial response among response-evaluable patients.'}, {'type': 'SECONDARY', 'title': 'Mean Fold Change in Gamma H2AX in Peripheral Blood Mono Nuclear Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A, Dose Level 1', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 70 mg/m2 Irinotecan (IRIN) and 50 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG001', 'title': 'Part A, Dose Level 2', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 70 mg/m2 Irinotecan (IRIN) and 65 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG002', 'title': 'Part A, Dose Level 3', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 90 mg/m2 Irinotecan (IRIN) and 65 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG003', 'title': 'Part A, Dose Level 4', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 90 mg/m2 Irinotecan (IRIN) and 85 mg/m2 AZD1775 (MK-1775)'}, {'id': 'OG004', 'title': 'Part A, Dose Level 5', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 90 mg/m2 Irinotecan (IRIN) and 110 mg/m2 AZD1775 (MK-1775)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '4.18', 'groupId': 'OG000'}, {'value': '0.45', 'spread': '0.24', 'groupId': 'OG001'}, {'value': '3.78', 'spread': '0.72', 'groupId': 'OG002'}, {'value': '2', 'spread': '2.17', 'groupId': 'OG003'}, {'value': '10', 'spread': '11.89', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 1 day', 'description': 'Mean (SD) of the increase in gamma H2AX at 4 hours versus baseline among patients in Part A stratified by dose level.', 'unitOfMeasure': 'Fold change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Part A patients with data available. Per study protocol, pharmacodynamics were not required for Parts B, C, or D, therefore, data were not collected and will not be collected.'}, {'type': 'SECONDARY', 'title': 'Number and Percentage of Part B Neuroblastoma Participants With MYCN Amplification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B, Neuroblastoma', 'description': 'Patients with relapsed or refractory neuroblastoma treated at the MTD/RP2D of 90 mg/m2 Irinotecan (IRIN) and 85 mg/m2 AZD1775 (MK-1775)'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed at Baseline', 'description': 'Frequency (%) of Part B Neuroblastoma participants with MYCN amplification.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only Part B eligible patients. Per study protocol, data for Parts A, C, and D were not and will not ever be collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A, Dose Level 1', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 70 mg/m2 Irinotecan (IRIN) and 50 mg/m2 AZD1775 (MK-1775)'}, {'id': 'FG001', 'title': 'Part A, Dose Level 2', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 70 mg/m2 Irinotecan (IRIN) and 65 mg/m2 AZD1775 (MK-1775)'}, {'id': 'FG002', 'title': 'Part A, Dose Level 3', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 90 mg/m2 Irinotecan (IRIN) and 65 mg/m2 AZD1775 (MK-1775)'}, {'id': 'FG003', 'title': 'Part A, Dose Level 4', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 90 mg/m2 Irinotecan (IRIN) and 85 mg/m2 AZD1775 (MK-1775)'}, {'id': 'FG004', 'title': 'Part A, Dose Level 5', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 90 mg/m2 Irinotecan (IRIN) and 110 mg/m2 AZD1775 (MK-1775)'}, {'id': 'FG005', 'title': 'Part A, PK Expansion', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at the MTD/RP2D of 90 mg/m2 Irinotecan (IRIN) and 110 mg/m2 AZD1775 (MK-1775)'}, {'id': 'FG006', 'title': 'Part B, Neuroblastoma', 'description': 'Patients with relapsed or refractory neuroblastoma treated at the MTD/RP2D of 90 mg/m2 Irinotecan (IRIN) and 85 mg/m2 AZD1775 (MK-1775)'}, {'id': 'FG007', 'title': 'Part C, Medulloblastoma/CNS PNET', 'description': 'Patients with relapsed or refractory Medulloblastoma/CNS PNET treated at the MTD/RP2D of 90 mg/m2 Irinotecan (IRIN) and 85 mg/m2 AZD1775 (MK-1775)'}, {'id': 'FG008', 'title': 'Part D, Rhabdomyosarcoma', 'description': 'Patients with relapsed or refractory Rhabdomyosarcoma treated at the MTD/RP2D of 90 mg/m2 Irinotecan (IRIN) and 85 mg/m2 AZD1775 (MK-1775)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '19'}, {'groupId': 'FG007', 'numSubjects': '10'}, {'groupId': 'FG008', 'numSubjects': '10'}]}, {'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'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '18'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '10'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '8'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}, {'value': '10', 'groupId': 'BG007'}, {'value': '10', 'groupId': 'BG008'}, {'value': '76', 'groupId': 'BG009'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A, Dose Level 1', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 70 mg/m2 Irinotecan (IRIN) and 50 mg/m2 AZD1775 (MK-1775)'}, {'id': 'BG001', 'title': 'Part A, Dose Level 2', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 70 mg/m2 Irinotecan (IRIN) and 65 mg/m2 AZD1775 (MK-1775)'}, {'id': 'BG002', 'title': 'Part A, Dose Level 3', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 90 mg/m2 Irinotecan (IRIN) and 65 mg/m2 AZD1775 (MK-1775)'}, {'id': 'BG003', 'title': 'Part A, Dose Level 4', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 90 mg/m2 Irinotecan (IRIN) and 85 mg/m2 AZD1775 (MK-1775)'}, {'id': 'BG004', 'title': 'Part A, Dose Level 5', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at 90 mg/m2 Irinotecan (IRIN) and 110 mg/m2 AZD1775 (MK-1775)'}, {'id': 'BG005', 'title': 'Part A, PK Expansion', 'description': 'Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors treated at the MTD/RP2D of 90 mg/m2 Irinotecan (IRIN) and 110 mg/m2 AZD1775 (MK-1775)'}, {'id': 'BG006', 'title': 'Part B, Neuroblastoma', 'description': 'Patients with relapsed or refractory neuroblastoma treated at the MTD/RP2D of 90 mg/m2 Irinotecan (IRIN) and 85 mg/m2 AZD1775 (MK-1775)'}, {'id': 'BG007', 'title': 'Part C, Medulloblastoma/CNS PNET', 'description': 'Patients with relapsed or refractory Medulloblastoma/CNS PNET treated at the MTD/RP2D of 90 mg/m2 Irinotecan (IRIN) and 85 mg/m2 AZD1775 (MK-1775)'}, {'id': 'BG008', 'title': 'Part D, Rhabdomyosarcoma', 'description': 'Patients with relapsed or refractory Rhabdomyosarcoma treated at the MTD/RP2D of 90 mg/m2 Irinotecan (IRIN) and 85 mg/m2 AZD1775 (MK-1775)'}, {'id': 'BG009', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '18', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '10', 'groupId': 'BG008'}, {'value': '64', 'groupId': 'BG009'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '12', 'groupId': 'BG009'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000', 'lowerLimit': '10', 'upperLimit': '19'}, {'value': '16', 'groupId': 'BG001', 'lowerLimit': '7', 'upperLimit': '19'}, {'value': '13.5', 'groupId': 'BG002', 'lowerLimit': '11', 'upperLimit': '15'}, {'value': '11', 'groupId': 'BG003', 'lowerLimit': '7', 'upperLimit': '20'}, {'value': '14.5', 'groupId': 'BG004', 'lowerLimit': '5', 'upperLimit': '20'}, {'value': '10.5', 'groupId': 'BG005', 'lowerLimit': '2', 'upperLimit': '19'}, {'value': '9', 'groupId': 'BG006', 'lowerLimit': '6', 'upperLimit': '19'}, {'value': '13.5', 'groupId': 'BG007', 'lowerLimit': '6', 'upperLimit': '20'}, {'value': '11', 'groupId': 'BG008', 'lowerLimit': '4', 'upperLimit': '16'}, {'value': '11.5', 'groupId': 'BG009', 'lowerLimit': '2', 'upperLimit': '20'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '31', 'groupId': 'BG009'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '45', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '8', 'groupId': 'BG009'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}, {'value': '65', 'groupId': 'BG009'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '10', 'groupId': 'BG009'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '9', 'groupId': 'BG008'}, {'value': '53', 'groupId': 'BG009'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-02', 'size': 2556897, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-08-04T09:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-01', 'studyFirstSubmitDate': '2014-03-13', 'resultsFirstSubmitDate': '2022-02-08', 'studyFirstSubmitQcDate': '2014-03-20', 'lastUpdatePostDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-09-08', 'studyFirstPostDateStruct': {'date': '2014-03-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD)', 'timeFrame': 'Up to 21 days', 'description': 'MTD is defined as the maximum doses of adavosertib and irinotecan hydrochloride at which fewer than one-third of patients experience dose limiting toxicities when receiving this combination.'}, {'measure': 'Number of Participants With Cycle 1 DLT', 'timeFrame': 'Up to 21 days', 'description': 'To define and describe the toxicities of AZD1755 (MK-1775) in combination with oral irinotecan administered on this schedule.'}, {'measure': 'Pharmacokinetic (PK) Parameters of Adavosertib in Terms of Systemic Exposure, AUC', 'timeFrame': 'Cycle 1 day 1 prior to the irinotecan infusion, prior to the adavosertib dose, 4 hours after the dose of adavosertib is given, and prior to the irinotecan dose on day 2', 'description': 'The PK parameters will be summarized by means and standard deviations'}, {'measure': 'Pharmacokinetic (PK) Parameters of Adavosertib in Terms of Systemic Exposure, Cmax', 'timeFrame': 'Cycle 1 day 1 prior to the irinotecan infusion, prior to the adavosertib dose, 4 hours after the dose of adavosertib is given, and prior to the irinotecan dose on day 2', 'description': 'The PK parameters will be summarized by means and standard deviations'}, {'measure': 'Pharmacokinetic (PK) Parameters of Adavosertib in Terms of Systemic Exposure, HL-Lambda (Half Life)', 'timeFrame': 'Cycle 1 day 1 prior to the irinotecan infusion, prior to the adavosertib dose, 4 hours after the dose of adavosertib is given, and prior to the irinotecan dose on day 2', 'description': 'The PK parameters will be summarized by means and standard deviations'}, {'measure': 'Pharmacokinetic (PK) Parameters of Adavosertib in Terms of Systemic Exposure, Tmax', 'timeFrame': 'Cycle 1 day 1 prior to the irinotecan infusion, prior to the adavosertib dose, 4 hours after the dose of adavosertib is given, and prior to the irinotecan dose on day 2', 'description': 'The PK parameters will be summarized by means and standard deviations'}], 'secondaryOutcomes': [{'measure': 'Number and Percentage of Participants With Best Overall Response With Partial or Complete Response', 'timeFrame': 'Up to 1 year', 'description': 'Frequency (%) of response-evaluable patients with best overall response of partial or complete response as determined by revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1).'}, {'measure': 'Mean Fold Change in Gamma H2AX in Peripheral Blood Mono Nuclear Cells', 'timeFrame': 'Up to 1 day', 'description': 'Mean (SD) of the increase in gamma H2AX at 4 hours versus baseline among patients in Part A stratified by dose level.'}, {'measure': 'Number and Percentage of Part B Neuroblastoma Participants With MYCN Amplification', 'timeFrame': 'Assessed at Baseline', 'description': 'Frequency (%) of Part B Neuroblastoma participants with MYCN amplification.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Central Nervous System Embryonal Tumor With Rhabdoid Features', 'Central Nervous System Embryonal Tumor, Not Otherwise Specified', 'Central Nervous System Ganglioneuroblastoma', 'Embryonal Tumor With Multilayered Rosettes, C19MC-Altered', 'Pineoblastoma', 'Primary Central Nervous System Neoplasm', 'Recurrent Childhood Central Nervous System Embryonal Neoplasm', 'Recurrent Malignant Solid Neoplasm', 'Recurrent Medulloblastoma', 'Recurrent Neuroblastoma', 'Recurrent Rhabdomyosarcoma', 'Refractory Malignant Solid Neoplasm', 'Refractory Medulloblastoma', 'Refractory Neuroblastoma', 'Refractory Rhabdomyosarcoma']}, 'descriptionModule': {'briefSummary': 'This phase I/II trial studies the side effects and best dose of adavosertib and irinotecan hydrochloride in treating younger patients with solid tumors that have come back (relapsed) or that have not responded to standard therapy (refractory). Adavosertib and irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To estimate the maximum tolerated dose (MTD) and/or recommended phase 2 dose of adavosertib (AZD1755 \\[MK-1775\\]) administered on days 1 through 5 every 21 days, in combination with oral irinotecan (irinotecan hydrochloride), to children with recurrent or refractory solid tumors.\n\nII. To define and describe the toxicities of AZD1755 (MK-1775) in combination with oral irinotecan administered on this schedule.\n\nIII. To characterize the pharmacokinetics of AZD1755 (MK-1775) in children with refractory cancer.\n\nSECONDARY OBJECTIVES:\n\nI. To preliminarily define the antitumor activity of AZD1755 (MK-1775) and irinotecan within the confines of a Phase 1 study.\n\nII. To obtain initial phase 2 efficacy data on the anti-tumor activity of AZD1755 (MK-1775) in combination with irinotecan administered to children with relapsed or refractory neuroblastoma, in children with relapsed or refractory medulloblastoma/CNS PNET (central nervous system primitive neuroectodermal tumor) and in children with relapsed or refractory rhabdomyosarcoma.\n\nIII. To investigate checkpoint over-ride by AZD1755 (MK-1775) via the mechanism-based pharmacodynamic (PD) biomarker of decreased cyclin-dependent kinase 1 (CDK1) phosphorylation in correlative and exploratory studies.\n\nIV. To evaluate potential predictive biomarkers of AZD1755 (MK-1775) sensitivity, including v-myc avian myelocytomatosis viral oncogene homolog (MYC), v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (MYCN), phosphorylated-WEE1 G2 checkpoint kinase (p-Wee1), enhancer of zeste homolog 2 (Drosophila) (EZH2) and gamma-H2A histone family, member gamma-(H2AX) in tumor tissues in correlative and exploratory studies.\n\nOUTLINE: This is a phase I, dose-escalation followed by a phase II study.\n\nPatients receive irinotecan hydrochloride orally (PO) and adavosertib PO on days 1-5. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed up periodically.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)\n* Part A: Patients with relapsed or refractory solid tumors, including patients with primary or metastatic CNS tumors\n* Part B: Patients with relapsed or refractory neuroblastoma\n* Part C: Patients with relapsed or refractory medulloblastoma or CNS embryonal tumors formally classified as PNET (pineoblastoma, CNS neuroblastoma, CNS ganglioneuroblastoma, embryonal tumor with multi-layered rosettes, medulloepithelioma, CNS embryonal tumor with rhabdoid features \\[INI1 intact\\] and CNS embryonal tumor, not otherwise specified)\n* Part D: Patients with relapsed or refractory rhabdomyosarcoma\n* Part A: Patients must have a body surface area \\>= 0.35 m\\^2 at the time of study enrollment if enrolling on dose levels 1-5; patients must have a body surface area \\>= 0.46 m\\^2 at the time of study enrollment if enrolling on dose level 0\n* Parts B, C, and D: Phase 2 Expansion: Patients must have a body surface area of \\> 0.49 m\\^2 at the time of study enrollment at the recommended phase 2 dose of AZD-1775\n* Part A: Patients must have either measurable or evaluable disease\n* Part B: Patients must have either measurable disease or must be evaluable for MIBG response without evidence of Response Evaluation Criteria in Solid Tumors (RECIST) measurable lesions; patients with neuroblastoma in bone marrow only are not eligible\n* Part C: Patients must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)\n* Part D: Patients must have measurable disease for Part D\n* Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life\n* Karnofsky \\>= 50% for patients \\> 16 years of age and Lansky \\>= 50 for patients =\\< 16 years of age; note: neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score\n* Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy\n* At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)\n* At least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair\n* At least 7 days after the last dose of a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair\n* At least 42 days after the completion of any type of immunotherapy, e.g. tumor vaccines\n* \\>= 21 days must have elapsed from infusion of lase dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =\\< 1\n* At least 14 days after local palliative radiation therapy (XRT) (small port); at least 150 days must have elapsed if prior traumatic brain injury (TBI), craniospinal XRT or if \\>= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial bone marrow radiation, including therapeutic doses of iobenguane (MIBG)\n* Stem cell Infusion without TBI: no evidence of active graft vs host disease and at least 84 days must have elapsed after transplant or stem cell infusion\n* Patients previously treated with irinotecan are eligible for this study\n* For patients with solid tumors without known bone marrow involvement: peripheral absolute neutrophil count (ANC) \\>= 1000/mm\\^3\n* For patients with solid tumors without known bone marrow involvement: platelet count \\>= 100,000/mm\\^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)\n* For patients with solid tumors without known bone marrow involvement: hemoglobin \\>= 8.0 g/dL (may receive red blood cell \\[RBC\\] transfusions)\n* Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity; at least 2 of every cohort of 3 patients must be evaluable for hematologic toxicity for Part A, the dose escalation part of the study; if dose-limiting hematologic toxicity is observed, all subsequent patients enrolled must be evaluable for hematologic toxicity\n* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 ml/min/1.73 m\\^2 or a serum creatinine based on age/gender as follows:\n\n * Age 1 to \\< 2 years: 0.6 mg/dL\n * Age 2 to \\< 6 years: 0.8 mg/dL\n * Age 6 to \\< 10 years: 1 mg/dL\n * Age 10 to \\< 13 years: 1.2 mg/dL\n * Age 13 to \\< 16 years: 1.5 mg/dL (males), 1.4 mg/dL (females)\n * Age \\>= 16 years: 1.7 mg/dL (males), 1.4 mg/dL (females)\n* Bilirubin (sum of conjugated + unconjugated) =\\< 1.5 x upper limit of normal (ULN) for age\n* Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) =\\< 135 U/L; for the purpose of this study, the ULN for SGPT is 45 U/L\n* Serum albumin \\>= 2 g/dL\n* Correct QT interval (QTc) =\\< 480 msec; Note: Patients should avoid concomitant medication known or suspected to prolong QTc interval or cause torsades de pointes; if possible, alternative agents should be considered; patients who are receiving drugs that prolong the QTc are eligible if the drug is necessary and no alternatives are available\n* Patients with seizure disorder may be enrolled if on non-enzyme inducing anticonvulsants and well controlled\n* Nervous system disorders (Common Terminology Criteria for Adverse Events version 5.0 \\[CTCAE v5.0\\]) resulting from prior therapy must be =\\< grade 2, with the exception of decreased tendon reflex (DTR); any grade of DTR is eligible\n* All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines\n* Tissue blocks or slides must be sent if available, with exclusions; if tissue blocks or slides are unavailable, the study chair must be notified prior to study enrollment\n* Patients must be able to swallow capsules\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding women may not be entered on this study as there is yet no available information regarding human fetal or teratogenic toxicities; pregnancy tests must be obtained in girls who are post-menarchal\n* Males or females of reproductive potential may not participate unless they have agreed to use an effective double barrier contraceptive method for the entire duration of protocol therapy and for 3 months (males) and 1 month (females) after study drug discontinuation\n* Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible\n* Patients who are currently receiving another investigational drug are not eligible\n* Patients who are currently receiving other anti-cancer agents are not eligible\n* Patients who are currently receiving drugs that are strong or moderate inhibitors and/or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) or sensitive CYP3A4 substrates and CYP3A4 substrates with a narrow therapeutic range are not eligible; the use of aprepitant as an antiemetic is prohibited due to early drug interaction data demonstrating increased exposure to AZD1775 (MK-1775); caution should be exercised with concomitant administration of AZD1755 (MK-1775) and agents that are sensitive substrates of cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8), 2C9 and 2C19, or substrates of this enzyme with narrow therapeutic ranges, as well as agents that are inhibitors or substrates of permeability glycoprotein (P-gp)\n* Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial\n* Patients must not have received enzyme inducing anticonvulsants for at least 14 days prior to enrollment\n* Patients with cardiac diseases ongoing or in the past 6 months (e.g. congestive heart failure, acute myocardial infarction, significant uncontrolled arrhythmias) are not eligible for this trial\n* Patients who have an uncontrolled infection are not eligible\n* Patients who have received a prior solid organ transplantation are not eligible\n* Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible\n* Patients with a history of allergic reaction to irinotecan, cephalosporins or a severe penicillin allergy are not eligible\n* Patients unable to swallow capsules whole are not eligible; nasogastric or gastric (G) tube administration is not allowed"}, 'identificationModule': {'nctId': 'NCT02095132', 'briefTitle': 'Adavosertib and Irinotecan Hydrochloride in Treating Younger Patients With Relapsed or Refractory Solid Tumors', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase 1/2 Study of AZD1775 (MK-1775) in Combination With Oral Irinotecan in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Tumors', 'orgStudyIdInfo': {'id': 'NCI-2014-00547'}, 'secondaryIdInfos': [{'id': 'NCI-2014-00547', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'ADVL1312', 'type': 'OTHER', 'domain': 'Pediatric Early Phase Clinical Trial Network'}, {'id': 'ADVL1312', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'UM1CA097452', 'link': 'https://reporter.nih.gov/quickSearch/UM1CA097452', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (irinotecan hydrochloride, adavosertib)', 'description': 'Patients receive irinotecan hydrochloride PO and adavosertib PO on days 1-5. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Adavosertib', 'Drug: Irinotecan Hydrochloride']}], 'interventions': [{'name': 'Adavosertib', 'type': 'DRUG', 'otherNames': ['AZD-1775', 'AZD1775', 'MK-1775', 'MK1775'], 'description': 'Given PO', 'armGroupLabels': ['Treatment (irinotecan hydrochloride, adavosertib)']}, {'name': 'Irinotecan Hydrochloride', 'type': 'DRUG', 'otherNames': ['Campto', 'Camptosar', 'Camptothecin 11', 'Camptothecin-11', 'CPT 11', 'CPT-11', 'Irinomedac', 'Irinotecan Hydrochloride Trihydrate', 'Irinotecan Monohydrochloride Trihydrate', 'U-101440E'], 'description': 'Given PO', 'armGroupLabels': ['Treatment (irinotecan hydrochloride, adavosertib)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': "Children's Hospital of Alabama", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital of Orange County", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Medical Center-Parnassus', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Medical Center-Mission Bay', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta - Egleston", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Lurie Children's Hospital-Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Riley Hospital for Children', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': "C S Mott Children's Hospital", 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota/Masonic Cancer Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Pittsburgh of UPMC", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "Saint Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Children's Hospital of Wisconsin", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Kristina A Cole', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'COG Phase I Consortium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}