Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-31 @ 5:35 AM
Study NCT ID:
NCT00354835
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2006-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012208', 'term': 'Rhabdomyosarcoma'}, {'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D009217', 'term': 'Myosarcoma'}, {'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D003609', 'term': 'Dactinomycin'}, {'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D014750', 'term': 'Vincristine'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'resultsreportingcoordinator@childrensoncologygroup.org', 'phone': '626-447-0064', 'title': 'Results Reporting Coordinator', 'organization': "Children's Oncology Group"}, 'certainAgreement': {'otherDetails': 'Must obtain prior Sponsor approval.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'All eligible patients were considered in the evaluation of adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Vincristine, Dactinomycin, Cyclophosphamide (VAC)', 'description': 'Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.\n\nDactinomycin: Given IV\n\nCyclophosphamide: Given IV\n\nVincristine Sulfate: Given IV\n\nRadiation Therapy: Undergo radiotherapy\n\nLaboratory Biomarker Analysis: Correlative studies\n\nQuestionnaire Administration: Ancillary studies', 'otherNumAtRisk': 222, 'otherNumAffected': 209, 'seriousNumAtRisk': 222, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'VAC Alternating With VI', 'description': 'Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.\n\nIrinotecan Hydrochloride: Given IV\n\nDactinomycin: Given IV\n\nCyclophosphamide: Given IV\n\nVincristine Sulfate: Given IV\n\nRadiation Therapy: Undergo radiotherapy\n\nLaboratory Biomarker Analysis: Correlative studies\n\nQuestionnaire Administration: Ancillary studies', 'otherNumAtRisk': 226, 'otherNumAffected': 213, 'seriousNumAtRisk': 226, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Abdominal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Abducens nerve disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Activated partial thromboplastin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 22, 'numAffected': 16}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Anal mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Anal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Anaphylaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 183, 'numAffected': 102}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 89, 'numAffected': 57}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Anorectal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 30, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 42, 'numAffected': 35}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Aphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Bladder infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Bladder spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Bronchial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Catheter related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Cognitive disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Conjunctivitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Cystitis noninfective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 26, 'numAffected': 23}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Dermatitis radiation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'CTCv4'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 63, 'numAffected': 51}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Dysesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Edema trunk', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Esophageal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'External ear inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Extraocular muscle paresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Eye disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Eye infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Eyelid function disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Facial nerve disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Facial pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 86, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 57, 'numAffected': 46}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'CTCv4'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Gastrointestinal disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'General disorders and administration site conditions - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'GGT increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Gum infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 6, 'numAffected': 4}, {'groupId': 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[{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 13, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Vaginal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Vaginal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Vagus nerve disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Vascular access complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'CTCv4'}, {'term': 'Vascular disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Vasovagal reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Voice alteration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 37, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Vulval infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Watering eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 32, 'numAffected': 23}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 235, 'numAffected': 100}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 219, 'numAffected': 96}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Wound complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'CTCv4'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'CTCv4'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}], 'seriousEvents': [{'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Death NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Gastrointestinal disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Hepatic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Hepatobiliary disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Intracranial hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'CTCv4'}, {'term': 'Nervous system disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Pharyngeal mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCv4'}, {'term': 'Radiation recall reaction (dermatologic)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'CTCv4'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCv4'}, {'term': 'Tracheal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'CTCv4'}, {'term': 'Treatment related secondary malignancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'CTCv4'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Event Free Survival (EFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vincristine, Dactinomycin, Cyclophosphamide (VAC)', 'description': 'Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.\n\nDactinomycin: Given IV Cyclophosphamide: Given IV Vincristine Sulfate: Given IV Radiation Therapy: Undergo radiotherapy Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies'}, {'id': 'OG001', 'title': 'VAC Alternating With Vincristine, Irinotecan (VI)', 'description': 'Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13,16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6255', 'groupId': 'OG000', 'lowerLimit': '0.5575', 'upperLimit': '0.6934'}, {'value': '0.5874', 'groupId': 'OG001', 'lowerLimit': '0.5178', 'upperLimit': '0.6569'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': 'Probability of no relapse, secondary malignancy, or death after 4 year in the study', 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Response Rate (RR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vincristine, Dactinomycin, Cyclophosphamide (VAC)', 'description': 'Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40;dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.'}, {'id': 'OG001', 'title': 'VAC Alternating With Vincristine, Irinotecan (VI)', 'description': 'Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13,16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6667', 'groupId': 'OG000', 'lowerLimit': '0.6047', 'upperLimit': '0.7287'}, {'value': '0.6726', 'groupId': 'OG001', 'lowerLimit': '0.6114', 'upperLimit': '0.7337'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Reporting Period 1 (Weeks 1 - 15)', 'description': 'Proportion of patients with complete or partial response. Complete Response (CR): Complete disappearance of the tumor confirmed at \\> 4 weeks; Partial Response (PR): At least 64% decrease in volume compared to the baseline; Overall Response (OR) = CR + PR.', 'unitOfMeasure': 'Proportion', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vincristine, Dactinomycin, Cyclophosphamide (VAC)', 'description': 'Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40;dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.'}, {'id': 'OG001', 'title': 'VAC Alternating With Vincristine, Irinotecan (VI)', 'description': 'Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13,16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7293', 'groupId': 'OG000', 'lowerLimit': '0.6669', 'upperLimit': '0.7917'}, {'value': '0.7223', 'groupId': 'OG001', 'lowerLimit': '0.6583', 'upperLimit': '0.7862'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': 'Probability of being alive after 4 years in the study.', 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Event Free Survival (EFS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vincristine, Dactinomycin, Cyclophosphamide (VAC)', 'description': 'Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40;dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6255', 'groupId': 'OG000', 'lowerLimit': '0.5575', 'upperLimit': '0.6934'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': 'Compare 4-year EFS using eligible participants only to the historical rate of 0.65 with IRSI-V. The 4-year EFS is probability of no relapse, secondary malignancy, or death after 4 years in the study. The Delayed (Week 10) Radiotherapy is from IRSI-V, and the number of participants of IRSI-V is unknown, but we have the rate of 0.65.', 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '17 ineligible participants were excluded.'}, {'type': 'SECONDARY', 'title': 'Local Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vincristine, Dactinomycin, Cyclophosphamide (VAC)', 'description': 'Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40;dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1757', 'groupId': 'OG000', 'lowerLimit': '0.1256', 'upperLimit': '0.2257'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Compare 2-year local failure rate to the historical rate of 0.13 with IRSI-V. The Delayed (Week 10) Radiotherapy is from IRSI-V, and the number of participants of IRSI-V is unknown, but we have the rate of 0.13.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '17 ineligible participants were excluded.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vincristine, Dactinomycin, Cyclophosphamide (VAC)', 'description': 'Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40;dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7293', 'groupId': 'OG000', 'lowerLimit': '0.6669', 'upperLimit': '0.7917'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': 'Compare 4-year OS using eligible participants only to the historical rate of 0.70 with IRSI-V. The 4-year OS is probability of being alive after 4 years in the study. The Delayed (Week 10) Radiotherapy is from IRSI-V, and the number of participants of IRSI-V is unknown, but we have the rate of 0.70.', 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '17 ineligible participants were excluded.'}, {'type': 'SECONDARY', 'title': 'Incidence of Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vincristine, Dactinomycin, Cyclophosphamide (VAC)', 'description': 'Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40;dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.'}, {'id': 'OG001', 'title': 'VAC Alternating With Vincristine, Irinotecan (VI)', 'description': 'Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13,16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2072', 'groupId': 'OG000', 'lowerLimit': '0.1539', 'upperLimit': '0.2605'}, {'value': '0.3673', 'groupId': 'OG001', 'lowerLimit': '0.3044', 'upperLimit': '0.4301'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 15 weeks', 'description': 'Grade 3 or 4 nausea, diarrhea, dehydration, radiation dermatitis, mucositis due to radiation. Severe and undesirable adverse event is considered as grade 3; Life-threatening or disabling adverse event is grade 4. Grade 4 is worse than grade 3.', 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Acute and Late Effects of VAC as Delivered on This Study to D9803 VAC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VAC (Weeks 1-15)', 'description': 'Reporting period 1 (acute)'}, {'id': 'OG001', 'title': 'VAC (Weeks 31 - 43)', 'description': 'Reporting period 3 (late)'}], 'classes': [{'title': 'Anemia', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Febrile Neutropenia', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Nausea or Hepatopathy', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Platelet Count Decreased', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'The incidence of anemia', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.2613', 'ciUpperLimit': '0.31', 'groupDescription': 'Compare incidence of Anemia to historical rate of 0.40 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. Comparing the incidence of anemia with VAC on ARST0531 to the historical rate of 0.40 with VAC on D9803. The 95% one-sided confidence interval for the incidence of anemia will be calculated and evaluated to see if the interval contains the null rate of 0.40.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000'], 'paramType': 'The incidence of nausea or hepatopathy', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.0270', 'ciUpperLimit': '0.0449', 'groupDescription': 'Compare incidence of Nausea or Hepatopathy to historical rate of 0.05 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of nausea or hepatopathy will be calculated and evaluated to see if the interval contains the null rate of 0.05.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000'], 'paramType': 'The incidence of febrile neutropenia', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.1351', 'ciUpperLimit': '0.1729', 'groupDescription': 'Compare incidence of Febrile Neutropenia to historical rate of 0.50 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of febrile neutropenia will be calculated and evaluated to see if the interval contains the null rate of 0.50.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000'], 'paramType': 'The incidence of platelet count decrease', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.1216', 'ciUpperLimit': '0.1577', 'groupDescription': 'Compare incidence of Platelet Count Decreased to historical rate of 0.70 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of platelet count decreased will be calculated and evaluated to see if the interval contains the null rate of 0.70.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000'], 'paramType': 'The incidence of vomiting', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.0405', 'ciUpperLimit': '0.0623', 'groupDescription': 'Compare incidence of Vomiting to historical rate of 0.15 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of vomiting will be calculated and evaluated to see if the interval contains the null rate of 0.15.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG001'], 'paramType': 'The incidence of anemia', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.2798', 'ciUpperLimit': '0.3329', 'groupDescription': 'Compare incidence of Anemia to historical rate of 0.40 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. 95% one-sided confidence interval for the incidence of anemia will be calculated and evaluated to see if the interval contains the null rate of 0.40.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG001'], 'paramType': 'The incidence of nausea or hepatopathy', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.0052', 'ciUpperLimit': '0.0137', 'groupDescription': 'Compare incidence of Nausea or Hepatopathy to historical rate of 0.05 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of nausea or hepatopathy will be calculated and evaluated to see if the interval contains the null rate of 0.05.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG001'], 'paramType': 'The incidence of febrile neutropenia', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.0881', 'ciUpperLimit': '0.1216', 'groupDescription': 'Compare incidence of Febrile Neutropenia to historical rate of 0.50 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of febrile neutropenia will be calculated and evaluated to see if the interval contains the null rate of 0.50.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG001'], 'paramType': 'The incidence of platelet count decrease', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.3264', 'ciUpperLimit': '0.3819', 'groupDescription': 'Compare incidence of Platelet Count Decreased to historical rate of 0.70 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of platelet count decreased will be calculated and evaluated to see if the interval contains the null rate of 0.70.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG001'], 'paramType': 'The incidence of vomiting', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.0104', 'ciUpperLimit': '0.0224', 'groupDescription': 'Compare incidence of Vomiting to historical rate of 0.15 from D9803, which is Randomized Study of VCR, Actinomycin-D, and CPM (VAC) vs. VAC alternating with VCR, Topotecan, and CPM (VTC) for Patients with Intermediate Risk RMS. The 95% one-sided confidence interval for the incidence of vomiting will be calculated and evaluated to see if the interval contains the null rate of 0.15.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 43 weeks', 'description': 'The toxicity rates will be estimated for each phase and course of treatment, and will be compared to the fixed rates under D9803 using one-sided lower confidence intervals for a single proportion without adjustment for multiple comparisons.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of patients with specific adverse events.'}, {'type': 'SECONDARY', 'title': 'Compare Event Free Survival (EFS) With Respect to the Level of % Change in FDG PET Maximum Standard Uptake Value (SUVmax) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '% Change in SUVmax From Baseline to Week 4 < 40%'}, {'id': 'OG001', 'title': '% Change in SUVmax From Baseline to Week 4 >= 40%'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2857', 'groupId': 'OG000', 'lowerLimit': '0.0000', 'upperLimit': '0.6204'}, {'value': '0.6364', 'groupId': 'OG001', 'lowerLimit': '0.4354', 'upperLimit': '0.8374'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': '4-year EFS (probability of no relapse, secondary malignancy, or death after 4 years in the study).', 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '452 participants were excluded due to ineligibility or absence of SUVmax evaluation at baseline and week 4.'}, {'type': 'SECONDARY', 'title': 'Compare Event Free Survival (EFS) With Respect to the Level of % Change in FDG PET Maximum Standard Uptake Value (SUVmax) at Week 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '% Change in SUVmax From Baseline to Week 15 < 40%'}, {'id': 'OG001', 'title': '% Change in SUVmax From Baseline to Week 15 >= 40%'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6667', 'groupId': 'OG000', 'lowerLimit': '0.2895', 'upperLimit': '1.0000'}, {'value': '0.5686', 'groupId': 'OG001', 'lowerLimit': '0.4303', 'upperLimit': '0.7070'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'description': '4-year EFS (probability of no relapse, secondary malignancy, or death after 4 years in the study)', 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '421 participants were excluded due to ineligibility or absence of SUVmax evaluation at baseline and week 15.'}, {'type': 'SECONDARY', 'title': 'Incidence of Toxicity Related to VI Treatment in Patients With UGT1A1 Genotype', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'UGT1A1 Genotype 6/6'}, {'id': 'OG001', 'title': 'UGT1A1 Genotype 6/7'}, {'id': 'OG002', 'title': 'UGT1A1 Genotype 7/7'}], 'classes': [{'title': 'Neutropenia, with or without Fever', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.99', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': "The incidences of grade 3 or higher neutropenia, with or without fever between UGT1A1 Genotypes (6/6, 6/7, 7/7) were compared by the Fisher's exact test.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.036', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': "The incidences of grade 3 or higher diarrhea between UGT1A1 Genotypes (6/6, 6/7, 7/7) were compared by Fisher's exact test.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4-9 (the first exposure to VI)', 'description': 'Severe and undesirable adverse event is considered as grade 3; Life-threatening or disabling adverse event is grade 4. Grade 4 is worse than grade 3.', 'unitOfMeasure': 'Counts', 'reportingStatus': 'POSTED', 'populationDescription': 'Ineligible patients are excluded. Only patients tested for the UGT1A1 genotypes are reported and included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Toxicity With CYP2B6 Genotypes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vincristine, Dactinomycin, Cyclophosphamide (VAC)', 'description': 'Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.'}], 'timeFrame': 'During the study', 'description': 'Incidence of toxicity related to VAC treatment in patients with CYP2B6 genotypes.', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was abandoned due to low incidence of toxicity. Data were not collected.'}, {'type': 'SECONDARY', 'title': 'Toxicity With GSTA1 and CYP2C9 Genotypes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vincristine, Dactinomycin, Cyclophosphamide (VAC)'}], 'timeFrame': 'During the study', 'description': 'Incidence of toxicity related to VAC treatment in patients with GSTA1 and CYP2C9 genotypes.', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was abandoned due to low incidence of toxicity. Data were not collected.'}, {'type': 'SECONDARY', 'title': 'Event Free Survival (EFS) by PAX Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PAX3', 'description': 'Fusion positive with PAX3 partner'}, {'id': 'OG001', 'title': 'PAX7', 'description': 'Fusion positive with PAX7 partner'}], 'classes': [{'categories': [{'measurements': [{'value': '0.51', 'groupId': 'OG000', 'lowerLimit': '0.39', 'upperLimit': '0.64'}, {'value': '0.66', 'groupId': 'OG001', 'lowerLimit': '0.37', 'upperLimit': '0.94'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 years', 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Only eligible patients who were tested for their fusion status and PAX partners.'}, {'type': 'SECONDARY', 'title': 'Incidence of Bladder Dysfunction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vincristine, Dactinomycin, Cyclophosphamide (VAC)', 'description': 'Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.'}, {'id': 'OG001', 'title': 'VAC Alternating With Vincristine, Irinotecan (VI)', 'description': 'Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3-6 years after enrollment', 'description': 'Number of patients with a summary score greater than 8.5', 'unitOfMeasure': 'Participant', 'reportingStatus': 'POSTED', 'populationDescription': '470 participants were excluded due to ineligibility or absence of the dysfunctional voiding and incontinence symptoms questionnaire.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vincristine, Dactinomycin, Cyclophosphamide (VAC)', 'description': 'Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.\n\nDactinomycin: Given IV Cyclophosphamide: Given IV Vincristine Sulfate: Given IV Radiation Therapy: Undergo radiotherapy Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies'}, {'id': 'FG001', 'title': 'VAC Alternating With Vincristine, Irinotecan (VI)', 'description': 'Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '239'}, {'groupId': 'FG001', 'numSubjects': '242'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '187'}, {'groupId': 'FG001', 'numSubjects': '181'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '61'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Disease progression or relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Refusal of further therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}], 'preAssignmentDetails': '481 excludes 33 ineligible cases (declared by the Study Chair) .'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'BG000'}, {'value': '242', 'groupId': 'BG001'}, {'value': '481', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Vincristine, Dactinomycin, Cyclophosphamide (VAC)', 'description': 'Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.'}, {'id': 'BG001', 'title': 'VAC Alternating With Vincristine, Irinotecan (VI)', 'description': 'Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '89.85', 'spread': '73.39', 'groupId': 'BG000'}, {'value': '97.86', 'spread': '82.66', 'groupId': 'BG001'}, {'value': '93.88', 'spread': '78.21', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '259', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '191', 'groupId': 'BG000'}, {'value': '204', 'groupId': 'BG001'}, {'value': '395', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '165', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '346', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 481}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-04', 'studyFirstSubmitDate': '2006-07-19', 'resultsFirstSubmitDate': '2016-07-08', 'studyFirstSubmitQcDate': '2006-07-19', 'lastUpdatePostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-27', 'studyFirstPostDateStruct': {'date': '2006-07-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event Free Survival (EFS)', 'timeFrame': '4 years', 'description': 'Probability of no relapse, secondary malignancy, or death after 4 year in the study'}, {'measure': 'Response Rate (RR)', 'timeFrame': 'Reporting Period 1 (Weeks 1 - 15)', 'description': 'Proportion of patients with complete or partial response. Complete Response (CR): Complete disappearance of the tumor confirmed at \\> 4 weeks; Partial Response (PR): At least 64% decrease in volume compared to the baseline; Overall Response (OR) = CR + PR.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': '4 years', 'description': 'Probability of being alive after 4 years in the study.'}], 'secondaryOutcomes': [{'measure': 'Event Free Survival (EFS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison', 'timeFrame': '4 years', 'description': 'Compare 4-year EFS using eligible participants only to the historical rate of 0.65 with IRSI-V. The 4-year EFS is probability of no relapse, secondary malignancy, or death after 4 years in the study. The Delayed (Week 10) Radiotherapy is from IRSI-V, and the number of participants of IRSI-V is unknown, but we have the rate of 0.65.'}, {'measure': 'Local Failure', 'timeFrame': '2 years', 'description': 'Compare 2-year local failure rate to the historical rate of 0.13 with IRSI-V. The Delayed (Week 10) Radiotherapy is from IRSI-V, and the number of participants of IRSI-V is unknown, but we have the rate of 0.13.'}, {'measure': 'Overall Survival (OS) Probability VAC and Early (Week 4) Radiotherapy Compared to Delayed (Week 10) Radiotherapy, Using IRSIV for Historic Comparison', 'timeFrame': '4 years', 'description': 'Compare 4-year OS using eligible participants only to the historical rate of 0.70 with IRSI-V. The 4-year OS is probability of being alive after 4 years in the study. The Delayed (Week 10) Radiotherapy is from IRSI-V, and the number of participants of IRSI-V is unknown, but we have the rate of 0.70.'}, {'measure': 'Incidence of Toxicity', 'timeFrame': 'Up to 15 weeks', 'description': 'Grade 3 or 4 nausea, diarrhea, dehydration, radiation dermatitis, mucositis due to radiation. Severe and undesirable adverse event is considered as grade 3; Life-threatening or disabling adverse event is grade 4. Grade 4 is worse than grade 3.'}, {'measure': 'Acute and Late Effects of VAC as Delivered on This Study to D9803 VAC', 'timeFrame': 'Up to 43 weeks', 'description': 'The toxicity rates will be estimated for each phase and course of treatment, and will be compared to the fixed rates under D9803 using one-sided lower confidence intervals for a single proportion without adjustment for multiple comparisons.'}, {'measure': 'Compare Event Free Survival (EFS) With Respect to the Level of % Change in FDG PET Maximum Standard Uptake Value (SUVmax) at Week 4', 'timeFrame': '4 years', 'description': '4-year EFS (probability of no relapse, secondary malignancy, or death after 4 years in the study).'}, {'measure': 'Compare Event Free Survival (EFS) With Respect to the Level of % Change in FDG PET Maximum Standard Uptake Value (SUVmax) at Week 15', 'timeFrame': '4 years', 'description': '4-year EFS (probability of no relapse, secondary malignancy, or death after 4 years in the study)'}, {'measure': 'Incidence of Toxicity Related to VI Treatment in Patients With UGT1A1 Genotype', 'timeFrame': 'Weeks 4-9 (the first exposure to VI)', 'description': 'Severe and undesirable adverse event is considered as grade 3; Life-threatening or disabling adverse event is grade 4. Grade 4 is worse than grade 3.'}, {'measure': 'Toxicity With CYP2B6 Genotypes', 'timeFrame': 'During the study', 'description': 'Incidence of toxicity related to VAC treatment in patients with CYP2B6 genotypes.'}, {'measure': 'Toxicity With GSTA1 and CYP2C9 Genotypes', 'timeFrame': 'During the study', 'description': 'Incidence of toxicity related to VAC treatment in patients with GSTA1 and CYP2C9 genotypes.'}, {'measure': 'Event Free Survival (EFS) by PAX Status', 'timeFrame': '4 years'}, {'measure': 'Incidence of Bladder Dysfunction', 'timeFrame': '3-6 years after enrollment', 'description': 'Number of patients with a summary score greater than 8.5'}]}, 'conditionsModule': {'conditions': ['Adult Rhabdomyosarcoma', 'Childhood Alveolar Rhabdomyosarcoma', 'Childhood Botryoid-Type Embryonal Rhabdomyosarcoma', 'Childhood Embryonal Rhabdomyosarcoma', 'Localized Childhood Soft Tissue Sarcoma', 'Rhabdomyosarcoma', 'Sarcoma', 'Stage I Adult Soft Tissue Sarcoma AJCC v7', 'Stage II Adult Soft Tissue Sarcoma AJCC v7', 'Stage III Adult Soft Tissue Sarcoma AJCC v7']}, 'referencesModule': {'references': [{'pmid': '31174239', 'type': 'DERIVED', 'citation': "Casey DL, Chi YY, Donaldson SS, Hawkins DS, Tian J, Arndt CA, Rodeberg DA, Routh JC, Lautz TB, Gupta AA, Yock TI, Wolden SL. Increased local failure for patients with intermediate-risk rhabdomyosarcoma on ARST0531: A report from the Children's Oncology Group. Cancer. 2019 Sep 15;125(18):3242-3248. doi: 10.1002/cncr.32204. Epub 2019 Jun 7."}, {'pmid': '30091945', 'type': 'DERIVED', 'citation': "Hawkins DS, Chi YY, Anderson JR, Tian J, Arndt CAS, Bomgaars L, Donaldson SS, Hayes-Jordan A, Mascarenhas L, McCarville MB, McCune JS, McCowage G, Million L, Morris CD, Parham DM, Rodeberg DA, Rudzinski ER, Shnorhavorian M, Spunt SL, Skapek SX, Teot LA, Wolden S, Yock TI, Meyer WH. Addition of Vincristine and Irinotecan to Vincristine, Dactinomycin, and Cyclophosphamide Does Not Improve Outcome for Intermediate-Risk Rhabdomyosarcoma: A Report From the Children's Oncology Group. J Clin Oncol. 2018 Sep 20;36(27):2770-2777. doi: 10.1200/JCO.2018.77.9694. Epub 2018 Aug 9."}], 'seeAlsoLinks': [{'url': 'https://nctn-data-archive.nci.nih.gov/', 'label': 'Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive'}]}, 'descriptionModule': {'briefSummary': 'This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work when given together with radiation therapy in treating patients with newly diagnosed rhabdomyosarcoma. Drugs used in chemotherapy, such as vincristine sulfate, dactinomycin, cyclophosphamide, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective when given together with radiation therapy in treating patients with rhabdomyosarcoma.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To compare the early response rates, failure-free survival (FFS), and survival of patients with intermediate-risk rhabdomyosarcoma (RMS) treated with surgery, radiotherapy, and vincristine (vincristine sulfate), dactinomycin and cyclophosphamide (VAC) or VAC alternating with vincristine, irinotecan (irinotecan hydrochloride) (VI).\n\nSECONDARY OBJECTIVES:\n\nI. To compare FFS, local control, and survival of patients with intermediate-risk RMS treated with VAC and early (week 4) radiotherapy vs delayed (week 10) radiotherapy, using data from Intergroup Rhabdomyosarcoma Study (IRS)-IV for historic comparison.\n\nII. To compare the acute and late effects of VAC to VAC alternating with VI, including the toxicity associated with concurrent VI and radiotherapy.\n\nIII. To compare the acute and late effects of VAC as delivered on this study to D9803 VAC.\n\nIV. To correlate change in fludeoxyglucose F-18 positron emission tomography (FDG-PET) maximum standard uptake value (SUVmax) from week 1 to week 4 and 15 with FFS.\n\nV. For VI treated patients, to correlate patient UDP glucuronosyltransferase 1 family, polypeptide A1 (UGT1A1) genotype with VI toxicity. VI. To correlate cytochrome P450, family 2, subfamily B, polypeptide 6 (CYP2B6), cytochrome P450, family 2, subfamily C, polypeptide 9 (CYP2C9), and glutathione S-transferase alpha 1 (GSTA1) genotypes with VAC toxicity.\n\nVII. To prospectively evaluate and validate gene expression values with the intent to define the best diagnostic predictors and more powerful prognostic classifiers.\n\nVIII. To assess the frequency of bladder dysfunction in patients with bladder, prostate, and pelvic sites of RMS 3-6 years after study enrollment.\n\nOUTLINE: Patients are randomized to 1 of 2 treatment arms within 42 days of initial surgery or biopsy.\n\nARM I (VAC): Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40.\n\nARM II (VAC/VI): Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-13,16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1,13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37.\n\nIn both arms, treatment continues in the absence of disease progression or unacceptable toxicity. Patients\\* in both arms also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4 (except patients with alveolar RMS rendered group I by amputation OR patients needing week 1 emergency radiotherapy for symptomatic spinal cord compression).\n\nNOTE: \\*Individualized local control plan that deviates from protocol-mandated radiotherapy allowed for patients =\\< 24 months of age.\n\nAfter completion of study treatment, patients are followed up every 2-4 months for 4 years and then annually for 5-10 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '49 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with newly diagnosed embryonal RMS, botryoid or spindle cell variants of embryonal RMS, ectomesenchymoma, or alveolar RMS are eligible for this study\n* Enrollment on COG-D9902 to confirm local histologic diagnosis with central pathology review is required for all patients\n* Patients may be enrolled on ARST0531 and start protocol treatment prior to receipt of central pathology review results\n* Patient must have Intermediate-risk RMS defined as:\n\n * Embryonal, botryoid, or spindle cell RMS, or ectomesenchymoma: stage 2 or 3 and group III OR\n * Alveolar RMS: stage 1-3 and group I-III\n* Staging ipsilateral retroperitoneal lymph node dissection (SIRLND) is required for all patients \\>= 10 years of age with paratesticular tumors and for patients \\< 10 years with clinically or radiographically involved lymph nodes (except when extensive lymph node involvement, defined as two or more lymph nodes \\> 2 cm in dimension, is identified by imaging studies)\n* Regional lymph node sampling or sentinel lymph node procedure is required for histologic evaluation in patients with extremity tumors\n* Clinically or radiographically enlarged nodes should be sampled for histologic evaluation\n* Detection of metastasis by optional FDG PET (not required for study enrollment); FDG PET may detect abnormalities suggestive of metastasis not identified by bone scan, computed tomography (CT), or bone marrow aspiration/biopsy; the prognostic significance of FDG PET-detected abnormalities is not clear; FDG PET-detected abnormalities MUST be confirmed to be metastases by an additional imaging modality (such as magnetic resonance imaging \\[MRI\\] or CT) OR pathologic confirmation; unless FDG PET abnormalities are confirmed by another imaging modality or biopsy, FDG PET abnormalities will NOT be considered evidence of metastasis\n* Patients must have a performance status of 0, 1, or 2; the Lansky performance score should be used for patients \\< 16 years and the Karnofsky performance score for patients \\>= 16 years\n* Patients who have received prior chemotherapy (excluding steroids) or radiation therapy, except for patients transferring from ARST0331 (low-risk study), are not eligible\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 * 1 month to \\< 6 months: 0.4 mg/dL\n * 6 months to \\< 1 year: 0.5 mg/dL\n * 1 to \\< 2 years: 0.6 mg/dL\n * 2 to \\< 6 years: 0.8 mgt/dL\n * 6 to \\< 10 years: 1 mg/dL\n * 10 to \\< 13 years: 1.2 mg/dL\n * 13 to \\< 16 years: 1.5 mg/dL (males) or 1.4 mg/dL (females)\n * \\>= 16 years: 1.7 mg/dL (males) or 1.4 mg/dL (females)\n* Patients with urinary tract obstruction by tumor must meet the renal function criteria AND must have unimpeded urinary flow established via decompression of the obstructed portion of the urinary tract\n* Total bilirubin =\\< 1.5 x upper limit of normal for age\n* Peripheral absolute neutrophil count (ANC) \\>= 750/uL\n* Platelet count \\>= 75,000/uL (transfusion independent)\n* No evidence of uncontrolled infection\n* Patients must be able to undergo radiation therapy, if necessary, as specified in the protocol\n* Female patients of childbearing potential must have a negative pregnancy test\n* Female patients who are breast feeding must agree to stop breast feeding\n* Sexually active patients of childbearing potential must be willing to use effective contraception during therapy and for at least 1 month after treatment is completed\n* All patients and/or their 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 studies must be met'}, 'identificationModule': {'nctId': 'NCT00354835', 'briefTitle': 'Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma', 'organization': {'class': 'NETWORK', 'fullName': "Children's Oncology Group"}, 'officialTitle': 'Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) Versus VAC Alternating With Vincristine and Irinotecan (VI) for Patients With Intermediate-Risk Rhabdomyosarcoma (RMS)', 'orgStudyIdInfo': {'id': 'ARST0531'}, 'secondaryIdInfos': [{'id': 'NCI-2009-00427', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '07-497'}, {'id': 'CDR0000487560'}, {'id': 'COG-ARST0531'}, {'id': 'ARST0531', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'ARST0531', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA180886', 'link': 'https://reporter.nih.gov/quickSearch/U10CA180886', 'type': 'NIH'}, {'id': 'U10CA098543', 'link': 'https://reporter.nih.gov/quickSearch/U10CA098543', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm I (chemotherapy, radiotherapy)', 'description': 'Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.', 'interventionNames': ['Drug: Cyclophosphamide', 'Biological: Dactinomycin', 'Other: Laboratory Biomarker Analysis', 'Other: Questionnaire Administration', 'Radiation: Radiation Therapy', 'Drug: Vincristine Sulfate']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (chemotherapy, radiotherapy)', 'description': 'Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4.', 'interventionNames': ['Drug: Cyclophosphamide', 'Biological: Dactinomycin', 'Drug: Irinotecan Hydrochloride', 'Other: Laboratory Biomarker Analysis', 'Other: Questionnaire Administration', 'Radiation: Radiation Therapy', 'Drug: Vincristine Sulfate']}], 'interventions': [{'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['(-)-Cyclophosphamide', '2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate', 'Carloxan', 'Ciclofosfamida', 'Ciclofosfamide', 'Cicloxal', 'Clafen', 'Claphene', 'CP monohydrate', 'CTX', 'CYCLO-cell', 'Cycloblastin', 'Cycloblastine', 'Cyclophospham', 'Cyclophosphamid monohydrate', 'Cyclophosphamide Monohydrate', 'Cyclophosphamidum', 'Cyclophosphan', 'Cyclophosphane', 'Cyclophosphanum', 'Cyclostin', 'Cyclostine', 'Cytophosphan', 'Cytophosphane', 'Cytoxan', 'Fosfaseron', 'Genoxal', 'Genuxal', 'Ledoxina', 'Mitoxan', 'Neosar', 'Revimmune', 'Syklofosfamid', 'WR- 138719'], 'description': 'Given IV', 'armGroupLabels': ['Arm I (chemotherapy, radiotherapy)', 'Arm II (chemotherapy, radiotherapy)']}, {'name': 'Dactinomycin', 'type': 'BIOLOGICAL', 'otherNames': ['Actinomycin A IV', 'Actinomycin C1', 'Actinomycin D', 'Actinomycin I1', 'Actinomycin IV', 'Actinomycin X 1', 'Actinomycin-[thr-val-pro-sar-meval]', 'Cosmegen', 'DACT', 'Dactinomycine', 'Lyovac Cosmegen', 'Meractinomycin'], 'description': 'Given IV', 'armGroupLabels': ['Arm I (chemotherapy, radiotherapy)', 'Arm II (chemotherapy, radiotherapy)']}, {'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 IV', 'armGroupLabels': ['Arm II (chemotherapy, radiotherapy)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I (chemotherapy, radiotherapy)', 'Arm II (chemotherapy, radiotherapy)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (chemotherapy, radiotherapy)', 'Arm II (chemotherapy, radiotherapy)']}, {'name': 'Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['Cancer Radiotherapy', 'ENERGY_TYPE', 'Irradiate', 'Irradiated', 'Irradiation', 'Radiation', 'Radiation Therapy, NOS', 'Radiotherapeutics', 'Radiotherapy', 'RT', 'Therapy, Radiation'], 'description': 'Undergo radiotherapy', 'armGroupLabels': ['Arm I (chemotherapy, radiotherapy)', 'Arm II (chemotherapy, radiotherapy)']}, {'name': 'Vincristine Sulfate', 'type': 'DRUG', 'otherNames': ['Kyocristine', 'Leurocristine Sulfate', 'Leurocristine, sulfate', 'Oncovin', 'Vincasar', 'Vincosid', 'Vincrex', 'Vincristine, sulfate'], 'description': 'Given IV', 'armGroupLabels': ['Arm I (chemotherapy, radiotherapy)', 'Arm II (chemotherapy, radiotherapy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': "Children's Hospital of Alabama", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Childrens Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner University Medical Center - Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72202-3591', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Hospital", 'geoPoint': {'lat': 34.74648, 'lon': 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