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 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
NCT ID:
NCT02021812
Description:
None
Frequency Threshold:
5
Time Frame:
Through 60 Months
Study:
NCT02021812
Study Brief:
Feasibility Study for GORE® TAG® Thoracic Branch Endoprosthesis to Treat Proximal Descending Thoracic Aortic Aneurysms
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Branched TAG® Device | Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis Branched TAG® Device | 8 | None | 20 | 31 | 30 | 31 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute post hemorrhagic anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.0 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.0 | View |
| Atrial fibrillation with rapid ventricular response | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.0 | View |
| Cardiac arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.0 | View |
| Chest pain - cardiac | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.0 | View |
| Congestive heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.0 | View |
| Heart block AV first degree | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.0 | View |
| Systolic heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.0 | View |
| Ventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.0 | View |
| Retinal vein occlusion | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 25.0 | View |
| Fecal incontinence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Gastrointestinal bleed | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Ischemic colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Lower gastrointestinal bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Adverse drug reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.0 | View |
| Debility | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.0 | View |
| Unknown cause of death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.0 | View |
| Aspiration pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Clostridium difficile infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Anemia postoperative | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.0 | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.0 | View |
| Hematoma traumatic | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.0 | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.0 | View |
| Postoperative hypotension | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.0 | View |
| Procedural hemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.0 | View |
| Vascular access site pseudoaneurysm | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.0 | View |
| Wound necrosis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.0 | View |
| Compartment syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | View |
| Degenerative joint disease | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | View |
| Lower extremities weakness of | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | View |
| Lumbar disc herniation | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | View |
| Adenocarcinoma of colon | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | View |
| Lung carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.0 | View |
| CSF leakage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.0 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.0 | View |
| Paresthesia lower limb | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.0 | View |
| Stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.0 | View |
| Device misdeployment (location) | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA Version 25.0 | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 25.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 25.0 | View |
| Renal disease | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 25.0 | View |
| Acute respiratory insufficiency | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Chronic obstructive pulmonary disease exacerbation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Ascending aortic aneurysm rupture | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 25.0 | View |
| Atherosclerotic cardiovascular disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 25.0 | View |
| Brachial artery thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 25.0 | View |
| Hypertension worsened | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 25.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 25.0 | View |
| Iliac artery dissection | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 25.0 | View |
| Leg ischemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 25.0 | View |
| Peripheral ischemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 25.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute post hemorrhagic anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.0 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.0 | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 25.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.0 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 25.0 | View |
| Macular degeneration | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 25.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 25.0 | View |
| Catheter site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.0 | View |
| Stent-graft endoleak type IA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.0 | View |
| Stent-graft endoleak type II | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.0 | View |
| Stent-graft endoleak type III | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 25.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 25.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.0 | View |
| Incision site hematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.0 | View |
| Incision site pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 25.0 | View |
| Electrolyte imbalance | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 25.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | View |
| Chest wall pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | View |
| Shoulder pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 25.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 25.0 | View |
| Thrombosis in device | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA Version 25.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 25.0 | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 25.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 25.0 | View |
| Oliguria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 25.0 | View |
| Atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Basilar atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Hypoxemia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Pulmonary edema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Respiratory insufficiency | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 25.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 25.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 25.0 | View |