Viewing Study NCT02521493

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Ignite Creation Date: 2025-12-25 @ 1:02 AM
Ignite Modification Date: 2026-02-22 @ 1:00 PM
Study NCT ID: NCT02521493
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2025-08-01
First Post: 2015-08-10
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D004314', 'term': 'Down Syndrome'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001215', 'term': 'Asparaginase'}, {'id': 'C001176', 'term': 'Leyk'}, {'id': 'C000718243', 'term': 'asparaginase erwinia chrysanthemi recombinant'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D008942', 'term': 'Mitoxantrone'}, {'id': 'D013866', 'term': 'Thioguanine'}], 'ancestors': [{'id': 'D000581', 'term': 'Amidohydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D000880', 'term': 'Anthraquinones'}, {'id': 'D000095322', 'term': 'Anthrones'}, {'id': 'D000873', 'term': 'Anthracenes'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'resultsreportingcoordinator@childrensoncologygroup.org', 'phone': '6264470064', 'title': 'Results Reporting Coordinator', 'organization': "Children's Oncology Group"}, 'certainAgreement': {'otherDetails': 'Must obtain prior Sponsor approval', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'While patients were on Protocol Therapy: Up to 5 courses, 28-day cycles', '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. All-Cause Mortality includes all deaths collected on the study. Ineligible patients are excluded from reporting of adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A (Standard Risk)', 'description': 'Patients with MRD \\<0.05%\n\n(This arm was closed to accrual and treatment with amendment #4A 01/07/2019)', 'otherNumAtRisk': 114, 'deathsNumAtRisk': 114, 'otherNumAffected': 84, 'seriousNumAtRisk': 114, 'deathsNumAffected': 12, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Arm B (High Risk)', 'description': 'Patients with MRD ≥ 0.05%', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 37, 'seriousNumAtRisk': 43, 'deathsNumAffected': 8, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'No Risk Stratification', 'description': 'No Risk Stratification', 'otherNumAtRisk': 122, 'deathsNumAtRisk': 122, 'otherNumAffected': 54, 'seriousNumAtRisk': 122, 'deathsNumAffected': 1, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Activated partial thromboplastin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alkalosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaphylaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Apnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood and lymphatic system disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Catheter related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Duodenal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Electrocardiogram QT corrected interval prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythema multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 27}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fibrinogen decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'GGT increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypercalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypermagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperuricemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infections and infestations - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infusion site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Laryngospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oral hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal and urinary disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin and subcutaneous tissue disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Small intestine infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Soft tissue infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stoma site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stridor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Typhlitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular access complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vasovagal reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vulval infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Adult respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infections and infestations - Other, specify: Metapneumovirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ischemia cerebrovascular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 122, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Event-free Survival (EFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A (Standard Risk)', 'description': 'Patients with MRD \\<0.05%\n\n(This arm was closed to accrual and treatment with amendment #4A 01/07/2019)'}, {'id': 'OG001', 'title': 'Arm B (High Risk)', 'description': 'Patients with MRD ≥ 0.05%'}], 'classes': [{'categories': [{'measurements': [{'value': '89.37', 'groupId': 'OG000', 'lowerLimit': '82', 'upperLimit': '93.8'}, {'value': '80.49', 'groupId': 'OG001', 'lowerLimit': '64.8', 'upperLimit': '89.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 years from study entry', 'description': 'The Kaplan-Meier method will be used to estimate 2-year EFS separately for standard risk and high risk patients. EFS is defined as the time from the end of Induction I to failure to achieve remission at the end of Induction II, relapse, occurrence of a second malignancy, or death.', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The High Risk Arm excludes the following patients: 1 Ineligible, 1 withdrawal, 1 death prior to Induction II. The No Risk Stratification Arm had zero patients for induction II treatment, as all patients went off study at the end of Induction I'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Length on Protocol Therapy', 'timeFrame': 'Up to 6 months from study entry', 'description': 'The mean number of days patients spent on protocol therapy.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion of Patients With an Early Death', 'timeFrame': 'Up to 1 month from study entry', 'description': 'The proportion of patients experiencing an early death in the first month.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Overall Survival (OS)', 'timeFrame': 'Up to 2 years from study entry', 'description': 'The Kaplan-Meier method will be used to estimate 2-year OS defined as the time from the end of Induction I to death.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion With Treatment Related Mortality', 'timeFrame': 'Up to 6 months from study entry', 'description': 'The proportion of patients experiencing a treatment related death will be reported along with a corresponding confidence interval.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion of Patients Experiencing a Relapse Risk', 'timeFrame': 'Up to 2 years from study entry', 'description': 'The proportion of patients experiencing a relapse after achieving remission will be reported along with a corresponding confidence interval.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Patients Experiencing Grade 3+ Adverse Events (AE)', 'timeFrame': 'Up to 6 months from study entry', 'description': 'The percentage of patients experiencing grade 3 or higher AEs will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Time to Absolute Neutrophil Count (ANC) Recovery', 'timeFrame': 'Up to 6 months from study entry', 'description': 'The mean time to recovery of ANC to at least 1000/uL will be reported.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Duration of Hospitalization', 'timeFrame': 'Up to 6 months from study entry', 'description': 'Mean number of days patients are hospitalized.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion of Patients With at Least 1 Infection', 'timeFrame': 'Up to 6 months from study entry', 'description': 'The proportion of patients having at least one infection will be reported.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A (Standard Risk)', 'description': 'Patients with MRD \\<0.05%\n\n(This arm was closed to accrual and treatment with amendment #4A 01/07/2019)'}, {'id': 'FG001', 'title': 'Arm B (High Risk)', 'description': 'Patients with MRD ≥ 0.05%'}, {'id': 'FG002', 'title': 'No Risk Stratification', 'description': 'No Risk Stratification'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '122'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '122'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Post Amd4A (MRD < 0.05%)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '115'}]}, {'type': 'No MRD result', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}, {'value': '280', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A (Standard Risk)', 'description': 'Patients with MRD \\<0.05%\n\n(This arm was closed to accrual and treatment with amendment #4A 01/07/2019)'}, {'id': 'BG001', 'title': 'Arm B (High Risk)', 'description': 'Patients with MRD ≥ 0.05%'}, {'id': 'BG002', 'title': 'No Risk Stratification', 'description': 'No Risk Stratification'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}, {'value': '280', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '0.7', 'groupId': 'BG000'}, {'value': '1.7', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '1.7', 'spread': '0.8', 'groupId': 'BG002'}, {'value': '1.7', 'spread': '0.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '142', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '138', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '254', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'New Zealand', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Saudi Arabia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-18', 'size': 4630512, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-12T18:50', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 280}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-22', 'studyFirstSubmitDate': '2015-08-10', 'resultsFirstSubmitDate': '2025-05-29', 'studyFirstSubmitQcDate': '2015-08-12', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-29', 'studyFirstPostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mean Length on Protocol Therapy', 'timeFrame': 'Up to 6 months from study entry', 'description': 'The mean number of days patients spent on protocol therapy.'}, {'measure': 'Proportion of Patients With an Early Death', 'timeFrame': 'Up to 1 month from study entry', 'description': 'The proportion of patients experiencing an early death in the first month.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 2 years from study entry', 'description': 'The Kaplan-Meier method will be used to estimate 2-year OS defined as the time from the end of Induction I to death.'}, {'measure': 'Proportion With Treatment Related Mortality', 'timeFrame': 'Up to 6 months from study entry', 'description': 'The proportion of patients experiencing a treatment related death will be reported along with a corresponding confidence interval.'}, {'measure': 'Proportion of Patients Experiencing a Relapse Risk', 'timeFrame': 'Up to 2 years from study entry', 'description': 'The proportion of patients experiencing a relapse after achieving remission will be reported along with a corresponding confidence interval.'}, {'measure': 'Percentage of Patients Experiencing Grade 3+ Adverse Events (AE)', 'timeFrame': 'Up to 6 months from study entry', 'description': 'The percentage of patients experiencing grade 3 or higher AEs will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.'}, {'measure': 'Mean Time to Absolute Neutrophil Count (ANC) Recovery', 'timeFrame': 'Up to 6 months from study entry', 'description': 'The mean time to recovery of ANC to at least 1000/uL will be reported.'}, {'measure': 'Mean Duration of Hospitalization', 'timeFrame': 'Up to 6 months from study entry', 'description': 'Mean number of days patients are hospitalized.'}, {'measure': 'Proportion of Patients With at Least 1 Infection', 'timeFrame': 'Up to 6 months from study entry', 'description': 'The proportion of patients having at least one infection will be reported.'}], 'primaryOutcomes': [{'measure': 'Event-free Survival (EFS)', 'timeFrame': 'Up to 2 years from study entry', 'description': 'The Kaplan-Meier method will be used to estimate 2-year EFS separately for standard risk and high risk patients. EFS is defined as the time from the end of Induction I to failure to achieve remission at the end of Induction II, relapse, occurrence of a second malignancy, or death.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia', 'Down Syndrome', 'Myelodysplastic Syndrome', 'Myeloid Leukemia Associated With Down Syndrome', 'Myeloproliferative Neoplasm']}, 'referencesModule': {'availIpds': [{'url': 'https://nctn-data-archive.nci.nih.gov/', 'type': 'Individual Participant Data Set', 'comment': 'Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive'}], 'references': [{'pmid': '41124669', 'type': 'DERIVED', 'citation': 'Berman JN, Verma A, Viola SA, Alonzo T, Wang YC, Brodersen LE, Loken MR, Beckman AK, Hirsch BA, Raimondi S, Chisholm KM, Ma X, Ries RE, Meshinchi S, Gamis AS, Schore RJ, Taub JW, Kolb EA, Cooper TM, Hitzler JK. Molecular Risk Markers Define Risk of Relapse in Myeloid Leukemia of Down syndrome Beyond Measurable Residual Disease. Blood Adv. 2025 Oct 22:bloodadvances.2025017837. doi: 10.1182/bloodadvances.2025017837. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'This phase III trial studies response-based chemotherapy in treating newly diagnosed acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Response-based chemotherapy separates patients into different risk groups and treats them according to how they respond to the first course of treatment (Induction I). Response-based treatment may be effective in treating acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome while reducing the side effects.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine the 2-year event-free-survival (EFS) for children with standard risk Down syndrome (DS) acute myeloid leukemia (AML) (minimal residual disease \\[MRD\\]-negative after one cycle of induction therapy) after elimination of high dose (HD) Ara-C (cytarabine) from the treatment regimen.\n\nII. To determine the 2-year EFS for children with high risk DS AML (MRD-positive after one cycle of induction therapy) after intensification of treatment equivalent to that used for high risk AML in children without DS.\n\nEXPLORATORY OBJECTIVES:\n\nI. To compare the feasibility and analytical characteristics of flow cytometry, polymerase chain reaction (PCR) and targeted error-corrected sequencing of GATA binding protein 1 (globin transcription factor 1) (GATA1) mutations as methods to detect MRD in DS AML.\n\nII. To establish a DS AML cell bank of viably frozen bone marrow samples collected at the end of induction and corresponding non-tumor deoxyribonucleic acid (DNA) samples collected at end of Induction 1.\n\nOUTLINE:\n\nINDUCTION I: Patients receive cytarabine intrathecally (IT) on day 1 and intravenously (IV) continuously over 96 hours, daunorubicin hydrochloride IV over 1-15 minutes, and thioguanine orally (PO) twice daily (BID) on days 1-4. Induction I continues for a minimum of 28 days.\n\nPatients are assigned to 1 of 2 treatment arms based on their MRD status after completion of Induction I.\n\nARM A (STANDARD RISK) (Closed to accrual and treatment with amendment #4A 01/07/2019):\n\nINDUCTION II: Patients receive cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV over 1-15 minutes, and thioguanine PO BID on days 1-4. Induction II continues for a minimum of 28 days.\n\nINDUCTION III: Patients receive cytarabine, daunorubicin hydrochloride, and thioguanine as in Induction II. Induction III continues for a minimum of 28 days.\n\nINTENSIFICATION I: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 60-120 minutes on days 1-3. Intensification I continues for a minimum of 28 days.\n\nINTENSIFICATION II: Patients receive cytarabine and etoposide as in Intensification I. Intensification II continues for a minimum of 28 days.\n\nARM B (HIGH RISK):\n\nINDUCTION II: Patients receive high dose cytarabine IV over 1-3 hours every 12 (Q12) hours on days 1-4 and mitoxantrone hydrochloride IV over 15-30 minutes on days 3-6. Induction II continues for a minimum of 28 days.\n\nINTENSIFICATION I: Patients receive high dose cytarabine IV over 1-3 hours Q12 hours and etoposide IV over 90-120 minutes on days 1-5. Intensification I continues for a minimum of 28 days.\n\nINTENSIFICATION II: Patients receive high dose cytarabine IV over 3 hours Q12 hours on days 1, 2, 8, and 9. Patients also receive asparaginase or asparaginase Erwinia chrysanthemi (E. carotovora) intramuscularly (IM) or IV over 30 minutes on days 2 and 9. Intensification II continues for a minimum of 28 days.\n\nAfter completion of study treatment, patients are followed up at 1 month, monthly for 12 months, every 3 months for 12 months, every 6 months for 3 years, annually for 10 years, and in case of relapse.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'minimumAge': '91 Days', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients must have constitutional trisomy 21 (Down syndrome) or trisomy 21 mosaicism (by karyotype or fluorescence in situ hybridization \\[FISH\\])\n* Patient has one of the following:\n\n * Patient has previously untreated de novo AML and meets the criteria for AML with \\>= 20% bone marrow blasts as set out in the World Health Organization (WHO) Myeloid Neoplasm classification\n\n * Attempts to obtain bone marrow either by aspirate or biopsy must be made unless clinically prohibitive; in cases where it is clinically prohibitive, peripheral blood with an excess of 20% blasts and in which adequate flow cytometric and cytogenetics/FISH testing is feasible can be substituted for the marrow exam at diagnosis\n * Patient has cytopenias and/or bone marrow blasts but does not meet the criteria for the diagnosis of AML (WHO Myeloid Neoplasm classification) because of \\< 20% marrow blasts and meets the criteria for a diagnosis of myelodysplastic syndrome (MDS)\n * For patients who do not meet criteria for AML or MDS as outlined above; patient has a history of transient myeloproliferative disorder (which may or may not have required chemotherapy intervention and:\n\n * Is \\> 8 weeks since resolution of transient myeloproliferative disease (TMD) with \\>= 5% blasts, OR\n * Has an increasing blast count (\\>= 5%) in serial bone marrow aspirates performed at least 4 weeks apart\n* Children who have previously received chemotherapy, radiation therapy or any anti-leukemic therapy are not eligible for this protocol, with the exception of cytarabine for the treatment of TMD\n* There are no minimal organ function requirements for enrollment on this study\n\n * Note: Previous cardiac repair with sufficient cardiac function is not an exclusion criteria\n* Each patient's parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human subjects research must be met\n\nExclusion Criteria:\n\n* Patients with promyelocytic leukemia (French-American-British \\[FAB\\] M3)\n* Prior therapy\n\n * Patients =\\< 30 days from the last dose of cytarabine used for treatment of TMD"}, 'identificationModule': {'nctId': 'NCT02521493', 'briefTitle': 'Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'Risk-Stratified Therapy for Acute Myeloid Leukemia in Down Syndrome', 'orgStudyIdInfo': {'id': 'AAML1531'}, 'secondaryIdInfos': [{'id': 'NCI-2015-00324', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'AAML1531'}, {'id': 's16-01673'}, {'id': 'AAML1531', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'AAML1531', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA180886', 'link': 'https://reporter.nih.gov/quickSearch/U10CA180886', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A (standard risk)', 'description': 'INDUCTION II: Patients receive cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV over 1-15 minutes, and thioguanine PO BID on days 1-4. Induction II continues for a minimum of 28 days.\n\nINDUCTION III: Patients receive cytarabine, daunorubicin hydrochloride, and thioguanine as in Induction II. Induction III continues for a minimum of 28 days.\n\nINTENSIFICATION I: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 60-120 minutes on days 1-3. Intensification I continues for a minimum of 28 days.\n\nINTENSIFICATION II: Patients receive cytarabine and etoposide as in Intensification I. Intensification II continues for a minimum of 28 days.\n\n(This arm is closed to accrual and treatment with amendment #4A 01/07/2019)', 'interventionNames': ['Drug: Cytarabine', 'Drug: Daunorubicin Hydrochloride', 'Drug: Etoposide', 'Other: Laboratory Biomarker Analysis', 'Drug: Thioguanine']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B (high risk)', 'description': 'INDUCTION II: Patients receive high dose cytarabine IV over 1-3 hours Q12 hours on days 1-4 and mitoxantrone hydrochloride IV over 15-30 minutes on days 3-6. Induction II continues for a minimum of 28 days.\n\nINTENSIFICATION I: Patients receive high dose cytarabine IV over 1-3 hours Q12 hours and etoposide IV over 90-120 minutes on days 1-5. Intensification I continues for a minimum of 28 days.\n\nINTENSIFICATION II: Patients receive high dose cytarabine IV over 3 hours Q12 hours on days 1, 2, 8, and 9. Patients also receive asparaginase or asparaginase Erwinia chrysanthemi IM or IV over 30 minutes on days 2 and 9. Intensification II continues for a minimum of 28 days.', 'interventionNames': ['Drug: Asparaginase', 'Drug: Asparaginase Erwinia chrysanthemi', 'Drug: Cytarabine', 'Other: Laboratory Biomarker Analysis', 'Drug: Mitoxantrone Hydrochloride']}], 'interventions': [{'name': 'Asparaginase', 'type': 'DRUG', 'otherNames': ['ASP-1', 'Asparaginase II', 'Asparaginase-E.Coli', 'Colaspase', 'Elspar', 'Kidrolase', 'L-Asnase', 'L-ASP', 'L-Asparaginase', 'L-Asparagine Amidohydrolase', 'Laspar', 'Lcf-ASP', 'Leucogen', 'Leunase', 'MK-965', 'Paronal', 'Re-82-TAD-15', 'Serasa', 'Spectrila'], 'description': 'Given IM or IV', 'armGroupLabels': ['Arm B (high risk)']}, {'name': 'Asparaginase Erwinia chrysanthemi', 'type': 'DRUG', 'otherNames': ['Asparaginase Erwinia chrysanthemi (Recombinant)-rywn', 'Asparaginase Erwinia chrysanthemi, Recombinant-rywn', 'Asparaginase Erwinia chrysanthemi-rywn', 'Crisantaspase', 'Crisantaspase Biobetter JZP-458', 'Crisantaspasum', 'Enrylaze', 'Erwinase', 'Erwinaze', 'JZP 458', 'JZP-458', 'JZP458', 'PF743', 'RC-P JZP-458', 'Recombinant Asparaginase erwinia chrysanthemi JZP-458', 'Recombinant Crisantaspase JZP-458', 'Recombinant Erwinia asparaginase JZP-458', 'Rylaze'], 'description': 'Given IM or IV', 'armGroupLabels': ['Arm B (high risk)']}, {'name': 'Cytarabine', 'type': 'DRUG', 'otherNames': ['.beta.-Cytosine arabinoside', '1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone', '1-.beta.-D-Arabinofuranosylcytosine', '1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone', '1-Beta-D-arabinofuranosylcytosine', '1.beta.-D-Arabinofuranosylcytosine', '2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-', '2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-', 'Alexan', 'Ara-C', 'ARA-cell', 'Arabine', 'Arabinofuranosylcytosine', 'Arabinosylcytosine', 'Aracytidine', 'Aracytin', 'Aracytine', 'Beta-Cytosine Arabinoside', 'CHX-3311', 'Cytarabinum', 'Cytarbel', 'Cytosar', 'Cytosine Arabinoside', 'Cytosine-.beta.-arabinoside', 'Cytosine-beta-arabinoside', 'Erpalfa', 'Starasid', 'Tarabine PFS', 'U 19920', 'U-19920', 'Udicil', 'WR-28453'], 'description': 'Given IT and IV', 'armGroupLabels': ['Arm A (standard risk)', 'Arm B (high risk)']}, {'name': 'Daunorubicin Hydrochloride', 'type': 'DRUG', 'otherNames': ['Cerubidin', 'Cerubidine', 'Cloridrato de Daunorubicina', 'Daunoblastin', 'Daunoblastina', 'Daunoblastine', 'Daunomycin Hydrochloride', 'Daunomycin, hydrochloride', 'Daunorubicin.HCl', 'Daunorubicini Hydrochloridum', 'FI-6339', 'Ondena', 'RP-13057', 'Rubidomycin Hydrochloride', 'Rubilem'], 'description': 'Given IV', 'armGroupLabels': ['Arm A (standard risk)']}, {'name': 'Etoposide', 'type': 'DRUG', 'otherNames': ['Demethyl Epipodophyllotoxin Ethylidine Glucoside', 'EPEG', 'Lastet', 'Toposar', 'Vepesid', 'VP 16', 'VP 16-213', 'VP 16213', 'VP-16', 'VP-16-213', 'VP-16213', 'VP16', 'VP16213'], 'description': 'Given IV', 'armGroupLabels': ['Arm A (standard risk)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm A (standard risk)', 'Arm B (high risk)']}, {'name': 'Mitoxantrone Hydrochloride', 'type': 'DRUG', 'otherNames': ['CL 232315', 'DHAD', 'DHAQ', 'Dihydroxyanthracenedione Dihydrochloride', 'Mitoxantrone Dihydrochloride', 'Mitoxantroni Hydrochloridum', 'Mitozantrone Hydrochloride', 'Mitroxone', 'Neotalem', 'Novantrone', 'Onkotrone', 'Pralifan'], 'description': 'Given IV', 'armGroupLabels': ['Arm B (high risk)']}, {'name': 'Thioguanine', 'type': 'DRUG', 'otherNames': ['2-Amino 6MP', '2-Amino-1,7-dihydro-6H-purine-6-thione', '2-Amino-6-mercaptopurine', '2-Amino-6-purinethiol', '2-Aminopurin-6-thiol', '2-Aminopurine-6(1H)-thione', '2-Aminopurine-6-thiol', '2-Aminopurine-6-thiol Hemihydrate', '2-Mercapto-6-aminopurine', '6-Amino-2-mercaptopurine', '6-Mercapto-2-aminopurine', '6-Mercaptoguanine', '6-TG', '6H-Purine-6-thione, 2-amino-1,7-dihydro- (9CI)', 'BW 5071', 'Lanvis', 'Tabloid', 'Thioguanine Hemihydrate', 'Thioguanine Hydrate', 'Tioguanin', 'Tioguanine', 'Wellcome U3B', 'WR-1141', 'X 27'], 'description': 'Given PO', 'armGroupLabels': ['Arm A (standard risk)']}]}, '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': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Providence Alaska Medical Center', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '85202', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': "Banner Children's at Desert", 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Childrens Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72202-3591', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Hospital", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90242', 'city': 'Downey', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Downey Medical Center', 'geoPoint': {'lat': 33.94001, 'lon': -118.13257}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': "Miller Children's and Women's Hospital Long Beach", 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 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