Ignite Creation Date:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2026-03-03 @ 3:54 PM
Study NCT ID:
NCT03689712
Status:
COMPLETED
Last Update Posted:
2023-10-24
First Post:
2018-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D013280', 'term': 'Stomatitis'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D019226', 'term': 'Oral Ulcer'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000707700', 'term': 'avasopasem manganese'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mholm@galeratx.com', 'phone': '484-615-2036', 'title': 'Megan Holm', 'organization': 'Galera Therapeutics'}, 'certainAgreement': {'otherDetails': "A copy of the proposed manuscript (or other document) for publication, presentation or other disclosure must be forwarded to the sponsor not less than 30 days prior to submission or presentation and the Principal Investigator shall comply with Sponsor's requests to delete or revise references to Confidential Information and consider all other comments of Sponsor in good faith.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the first dose of GC4419 (avasopasem manganese)/Placebo until 30 days following the last dose of GC4419 (avasopasem manganese)/Placebo, IMRT, or chemotherapy (whichever was later). Timeframe for collection of adverse events was approximately 10 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'GC4419 (Avasopasem Manganese) 90 mg', 'description': 'GC4419 90mg: 60 minute IV infusion', 'otherNumAtRisk': 241, 'deathsNumAtRisk': 241, 'otherNumAffected': 240, 'seriousNumAtRisk': 241, 'deathsNumAffected': 20, 'seriousNumAffected': 81}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo: 60 minute IV infusion', 'otherNumAtRisk': 166, 'deathsNumAtRisk': 166, 'otherNumAffected': 166, 'seriousNumAtRisk': 166, 'deathsNumAffected': 10, 'seriousNumAffected': 52}], 'otherEvents': [{'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 465, 'numAffected': 212}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 329, 'numAffected': 155}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 449, 'numAffected': 207}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 319, 'numAffected': 137}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 280, 'numAffected': 146}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 251, 'numAffected': 113}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 278, 'numAffected': 170}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 238, 'numAffected': 124}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 236, 'numAffected': 154}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 194, 'numAffected': 102}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Radiation Skin Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 222, 'numAffected': 126}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 181, 'numAffected': 104}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 259, 'numAffected': 135}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 137, 'numAffected': 77}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Weight Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 222, 'numAffected': 116}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 148, 'numAffected': 80}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 212, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 41, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 192, 'numAffected': 137}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 167, 'numAffected': 119}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 163, 'numAffected': 129}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 152, 'numAffected': 104}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}], 'seriousEvents': [{'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Failure to Thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Lung Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Asethenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Device Malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Pneumonia Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Hepatitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Weight Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Abdominal Wall Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Accidental Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Bactaraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Cardio-respiratory Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Cholecystitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Corona Virus Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Device Occulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Device Related Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Euglycaemic Diabetic Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Gastrostomy Tube Removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Gastrostomy Tube Site Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Haemorrhoidal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Hypercoagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Hypernatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Laryngeal Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Lipase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Metastases to Peritoneum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Muscle Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Neutropenic Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Oropharyngeal Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Parotitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Sinus Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Skin Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Staphylococcal Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Stoma Site Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 241, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cumulative Incidence of Severe Oral Mucositis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GC4419 (Avasopasem Manganese) 90mg', 'description': 'GC4419: 60 minute IV infusion'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: 60 minute IV infusion'}], 'classes': [{'categories': [{'measurements': [{'value': '53.8', 'groupId': 'OG000'}, {'value': 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{'type': 'Intent to Treat Population', 'comment': "Intent-to-Treat (ITT) population includes all randomized subjects who received at least one dose of GC4419/Placebo, with the exception of the 28 subjects whose treatment course was discontinued during the Sponsor's voluntary suspension of dosing.", 'achievements': [{'groupId': 'FG000', 'numSubjects': '241'}, {'groupId': 'FG001', 'numSubjects': '166'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '165'}, {'groupId': 'FG001', 'numSubjects': '111'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 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'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '202', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '351', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '222', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '382', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '219', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '377', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '208', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '350', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': "Intent-to-Treat (ITT) population includes all randomized subjects who received at least one dose of GC4419/Placebo, with the exception of the 28 subjects whose treatment course was discontinued during the Sponsor's voluntary suspension of dosing."}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-13', 'size': 1589673, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-12-21T14:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 455}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-19', 'studyFirstSubmitDate': '2018-09-27', 'resultsFirstSubmitDate': '2023-02-15', 'studyFirstSubmitQcDate': '2018-09-27', 'lastUpdatePostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-12', 'studyFirstPostDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative Incidence of Severe Oral Mucositis', 'timeFrame': 'From the first IMRT fraction through the end of the study treatment period (completion of study drug administration, IMRT and chemotherapy), which is estimated to be 7 weeks.', 'description': 'Cumulative incidence of severe oral mucositis is defined as the proportion of subjects with any occurrence of WHO Grade 3 to 4 OM, during the Study Treatment Period. Incidence of severe OM is defined as any occurrence of WHO Grade 3 or 4 OM through the last IMRT fraction after the start of IMRT. Incidence was imputed using multiple imputation for subjects with incomplete follow-up for severe OM through 60 Gy who did not have an occurrence of severe OM before the last IMRT fraction.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oral Mucositis', 'Superoxide Dismutase Mimetic', 'Cisplatin', 'Intensity-Modulated Radiation Therapy', 'Chemoradiation', 'OM', 'IMRT', 'Head and Neck Cancer', 'Squamous Cell Carcinoma', 'SCC', 'Oral Cavity', 'Oropharnyx', 'Mouth Sores', 'avasopasem mangenese'], 'conditions': ['Oral Mucositis']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Anderson CM, Lee CM, Kelley JR, et al. ROMAN: Phase 3 trial of avasopasem manganese (GC4419) for severe oral mucositis (SOM) in patients receiving chemoradiotherapy (CRT) for locally advanced, nonmetastatic head and neck cancer (LAHNC). Journal of Clinical Oncology 2022 40:16_suppl, 6005-6005'}, {'type': 'BACKGROUND', 'citation': 'Saunders D, Lee C, Kelley J, et al. ROMAN: Phase 3 trial of avasopasem to reduce chemoradiotherapy (CRT)-related severe oral mucositis (SOM) in patients with head and neck cancer (HNC). Support Care Cancer 30 (Suppl 1), 1-207 (2022).'}, {'pmid': '41127563', 'type': 'DERIVED', 'citation': 'Anderson C, Lee CM, Kelley JR, Walker GV, Dunlap NE, Bar-Ad VC, Miller DA, King VJ, Peddada AV, Ciuba DF, Vincent F, Muzyka BC, Gillespie-Twardy AL, Sonis ST, Holmlund J, Beardsley RA, Kennedy EP, Saunders D. Avasopasem manganese treatment for severe oral mucositis from chemoradiotherapy for locally advanced head and neck cancer: phase 3 randomized controlled trial (ROMAN). EClinicalMedicine. 2025 Oct 8;89:103539. doi: 10.1016/j.eclinm.2025.103539. eCollection 2025 Nov.'}, {'pmid': '34145168', 'type': 'DERIVED', 'citation': 'Squillace S, Salvemini D. Nitroxidative stress in pain and opioid-induced adverse effects: therapeutic opportunities. Pain. 2022 Feb 1;163(2):205-213. doi: 10.1097/j.pain.0000000000002347. No abstract available.'}, {'pmid': '31618127', 'type': 'DERIVED', 'citation': 'Anderson CM, Lee CM, Saunders DP, Curtis A, Dunlap N, Nangia C, Lee AS, Gordon SM, Kovoor P, Arevalo-Araujo R, Bar-Ad V, Peddada A, Colvett K, Miller D, Jain AK, Wheeler J, Blakaj D, Bonomi M, Agarwala SS, Garg M, Worden F, Holmlund J, Brill JM, Downs M, Sonis ST, Katz S, Buatti JM. Phase IIb, Randomized, Double-Blind Trial of GC4419 Versus Placebo to Reduce Severe Oral Mucositis Due to Concurrent Radiotherapy and Cisplatin For Head and Neck Cancer. J Clin Oncol. 2019 Dec 1;37(34):3256-3265. doi: 10.1200/JCO.19.01507. Epub 2019 Oct 16.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the phase 3, clinical study is to determine if GC4419 (avasopasem manganese) administered prior to intensity-modulated radiation therapy (IMRT) reduces the severity of radiation induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* squamous cell carcinoma of the head and neck\n* treatment plan to receive IMRT delivered as single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose of 60-72 Gy\n* Treatment plan to receive standard cisplatin monotherapy\n* Age 18 years or older\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Adequate hematologic, renal and liver function\n* Negative serum pregnancy test\n* Use of effective contraception\n\nExclusion Criteria:\n\n* Tumor of the lips, larynx, hypopharynx, nasopharynx, sinuses, or salivary glands\n* Metastatic disease\n* Prior radiotherapy to the region of the study cancer or adjacent anatomical\n* Prior induction chemotherapy\n* Receiving any approved or investigational anti-cancer agent other than those provided for in this study\n* Concurrent participation in another interventional clinical study\n* Inability to eat soft solid food at baseline\n* Malignant tumors other than HNC within the last 5 years\n* Active infectious disease excluding oral candidiasis\n* Presence of oral mucositis at baseline\n* Known history of HIV or active hepatitis B/C\n* Female patients who are pregnant or breastfeeding\n* Known allergies or intolerance to cisplatin and similar platinum-containing compounds\n* Requirement for concurrent treatment with nitrates or other drugs that may create a risk for a precipitous decrease in blood pressure'}, 'identificationModule': 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