Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-26 @ 10:16 PM
Ignite Modification Date: 2025-12-26 @ 10:16 PM
NCT ID: NCT03689712
Description: None
Frequency Threshold: 3
Time Frame: 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
Study: NCT03689712
Study Brief: ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
GC4419 (Avasopasem Manganese) 90 mg GC4419 90mg: 60 minute IV infusion 20 None 81 241 240 241 View
Placebo Placebo: 60 minute IV infusion 10 None 52 166 166 166 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 21 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 21 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21 View
Failure to Thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 21 View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 21 View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 21 View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 21 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA version 21 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21 View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 21 View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 21 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21 View
Lung Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21 View
Asethenia SYSTEMATIC_ASSESSMENT General disorders MedDRA version 21 View
Decreased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 21 View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 21 View
Device Malfunction SYSTEMATIC_ASSESSMENT Product Issues MedDRA version 21 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA version 21 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 21 View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 21 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21 View
Pneumonia Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 21 View
Acute Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 21 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 21 View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 21 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21 View
Hepatitis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 21 View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA version 21 View
Odynophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21 View
Weight Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 21 View
Abdominal Wall Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21 View
Accidental Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 21 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 21 View
Bactaraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21 View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 21 View
Cardio-respiratory Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 21 View
Cholecystitis Acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA version 21 View
Corona Virus Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA version 21 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 21 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 21 View
Device Occulsion SYSTEMATIC_ASSESSMENT Product Issues MedDRA version 21 View
Device Related Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21 View
Euglycaemic Diabetic Ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 21 View
Gastrostomy Tube Removal SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA version 21 View
Gastrostomy Tube Site Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 21 View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21 View
Haemorrhoidal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21 View
Hypercoagulation SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 21 View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 21 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 21 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 21 View
Hypovolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA version 21 View
Laryngeal Oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 21 View
Lipase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 21 View
Metastases to Peritoneum SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 21 View
Muscle Haemorrhage SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA version 21 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA version 21 View
Neutropenic Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21 View
Oropharyngeal Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21 View
Parotitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 21 View
Sinus Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA version 21 View
Skin Ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA version 21 View
Staphylococcal Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21 View
Stoma Site Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 21 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 21 View
Tumour Haemorrhage SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version 21 View
Upper Gastrointestinal Haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 21 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 21 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21 View
Oropharyngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 21 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA version 21 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21 View
Radiation Skin Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA version 21 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21 View
Weight Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA version 21 View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 21 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 21 View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 21 View