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:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-25 @ 8:02 PM
NCT ID:
NCT02603835
Description:
Adverse events were reported throughout the trial for all subjects, including at each protocol-specified follow-up assessment period, i.e., post-index procedure, hospital discharge, 30-day follow-up, 6-month follow-up and 1 year follow-up.
Frequency Threshold:
1
Time Frame:
1 year
Study:
NCT02603835
Study Brief:
Evaluation of Intracoronary Hyperoxemic Oxygen Therapy in Anterior Acute Myocardial Infarction Patients (IC-HOT)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| SSO2 Therapy | Delivery of SSO2 Therapy for 60 minutes selectively into the left main coronary artery (LMCA) using the TherOx DownStream System along with a single use disposable device called the TherOx DownStream Cartridge and a commercially available, qualified SSO2 delivery catheter | 0 | None | 27 | 100 | 68 | 100 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Angina Pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Atrial Flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Cardiac Arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Cardiac Failure Congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Ischaemic Cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Torsade de Pointes | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Ventricular Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Blindness | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.0 | View |
| Haematemesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Non-Cardiac Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Vascular Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Acute Kidney Injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.0 | View |
| Percutaneous Coronary Intervention | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 20.0 | View |
| Aortic Valve Replacement | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 20.0 | View |
| Coronary Artery Bypass | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 20.0 | View |
| Haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.0 | View |
| Aortic Stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Angina Pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Cardiac Failure Congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Ventricular Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Acute Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Cardiac Ventricular Thrombosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Ischaemic Cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Cardiac Arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Dyspnoea Exertional | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Arteriospasm Coronary | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Atrial Flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Chest Pain | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Pericarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Pulmonary Oedema | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Sinus Arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Supraventricular Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Torsade de Pointes | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Ventricular Extrasystoles | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Ventricular Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Ventricular Hypokinesia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 20.0 | View |
| Ear Pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 20.0 | View |
| Blindness | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.0 | View |
| Vision Blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 20.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Abdominal Discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Consitpation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Gastric Ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Gastroesophageal Reflux Disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Gingival Bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Haematemesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 20.0 | View |
| Non-Cardiac Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Vascular Stent Thrombosis | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 20.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Acute Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Urinary Tract Infection Fungal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 20.0 | View |
| Animal Bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Periorbital Haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Vascular Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 20.0 | View |
| Blood Electrolytes Abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Ejection Fraction Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 20.0 | View |
| Gout | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.0 | View |
| Hyperlipidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.0 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.0 | View |
| Dyslipidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 20.0 | View |
| Pain In Extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Flank Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Intervertebral Disc Protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Limb Discomfort | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Plantar Fasciitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Transient Ischaemic Attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 20.0 | View |
| Device Operational Issue | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA 20.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.0 | View |
| Mental Status Changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 20.0 | View |
| Acute Kidney Injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.0 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 20.0 | View |
| Uterine Haemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 20.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Productive Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Sleep Apnoea Syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | View |
| Subcutaneous Emphysema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 20.0 | View |
| Aortic Valve Replacement | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 20.0 | View |
| Coronary Artery Bypass | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 20.0 | View |
| Mitral Valve Replacement | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 20.0 | View |
| Percutaneous Coronary Intervention | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 20.0 | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.0 | View |
| Haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.0 | View |
| Aortic Stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 20.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 20.0 | View |