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:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
NCT ID:
NCT02542267
Description:
None
Frequency Threshold:
5
Time Frame:
36 months
Study:
NCT02542267
Study Brief:
In-Stent Restenosis Post-Approval Study
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Gore VIABAHN Endoprosthesis | Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery Gore VIABAHN Endoprosthesis | 13 | None | 70 | 108 | 30 | 108 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 24.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 24.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 24.0 | View |
| Colon stenosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 24.0 | View |
| Esophageal ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 24.0 | View |
| Gastrointestinal bleed | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 24.0 | View |
| Biliary colic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 24.0 | View |
| Bilateral pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 24.0 | View |
| Atrial fibrillation with rapid ventricular response | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 24.0 | View |
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 24.0 | View |
| Atrioventricular junctional escape rhythm | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 24.0 | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 24.0 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 24.0 | View |
| Chest pain - cardiac | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 24.0 | View |
| Congestive cardiac failure aggravated | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 24.0 | View |
| Congestive heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 24.0 | View |
| Decompensation cardiac | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 24.0 | View |
| Non ST segment elevation myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 24.0 | View |
| Non STEMI | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 24.0 | View |
| Paroxysmal atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 24.0 | View |
| Sick sinus syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 24.0 | View |
| Triple vessel disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 24.0 | View |
| Unstable angina | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 24.0 | View |
| Gastrointestinal bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 24.0 | View |
| Lower gastrointestinal bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 24.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 24.0 | View |
| Rectal prolapse | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 24.0 | View |
| Retroperitoneal bleed | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 24.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 24.0 | View |
| Delayed healing of wound | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 24.0 | View |
| In-stent arterial restenosis | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 24.0 | View |
| In-stent arterial stenosis | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 24.0 | View |
| Systemic inflammatory response syndrome | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 24.0 | View |
| Unknown cause of death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 24.0 | View |
| Vessel puncture site hematoma | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 24.0 | View |
| Weakness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 24.0 | View |
| Wound healing delayed | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 24.0 | View |
| Acute cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 24.0 | View |
| Bile duct stricture | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 24.0 | View |
| Cellulitis genital organ (male) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 24.0 | View |
| Cellulitis of leg | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 24.0 | View |
| Clostridium difficile colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 24.0 | View |
| Febrile infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 24.0 | View |
| Gangrene peripheral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 24.0 | View |
| Infectious diarrhea | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 24.0 | View |
| Influenza A virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 24.0 | View |
| Influenza B virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 24.0 | View |
| Lobar pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 24.0 | View |
| Osteomyelitis of the foot | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 24.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 24.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 24.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 24.0 | View |
| Broken bones | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 24.0 | View |
| Drug overdose accidental | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 24.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 24.0 | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 24.0 | View |
| Fractured hip | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 24.0 | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 24.0 | View |
| Incisional hernia | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 24.0 | View |
| Jaw fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 24.0 | View |
| Pseudoaneurysm | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 24.0 | View |
| Pulmonary contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 24.0 | View |
| Radiation pneumonitis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 24.0 | View |
| Diabetes mellitus inadequate control | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 24.0 | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 24.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 24.0 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 24.0 | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 24.0 | View |
| Hypoglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 24.0 | View |
| Compartment syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 24.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 24.0 | View |
| Rhabdomyolysis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 24.0 | View |
| B-cell lymphoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.0 | View |
| Malignant neoplasm of hypopharynx | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.0 | View |
| Renal cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.0 | View |
| Squamous cell carcinoma of lung | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.0 | View |
| Urothelial carcinoma urethra | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.0 | View |
| Carotid artery disease | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 24.0 | View |
| Cerebral hemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 24.0 | View |
| Cerebral infarct | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 24.0 | View |
| Cerebral infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 24.0 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 24.0 | View |
| Grand mal seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 24.0 | View |
| Hemiparesis (left) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 24.0 | View |
| Internal carotid artery stenosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 24.0 | View |
| Ischemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 24.0 | View |
| Near syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 24.0 | View |
| Seizures | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 24.0 | View |
| Stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 24.0 | View |
| Subarachnoid hemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 24.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 24.0 | View |
| Transient ischemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 24.0 | View |
| Tremor aggravated | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 24.0 | View |
| Device occlusion | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA Version 24.0 | View |
| Thrombosis in device | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA Version 24.0 | View |
| Mental status changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 24.0 | View |
| Acute kidney failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 24.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 24.0 | View |
| Acute retention of urine | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 24.0 | View |
| Chronic kidney disease | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 24.0 | View |
| Renal artery stenosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 24.0 | View |
| Vaginal prolapse | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 24.0 | View |
| Acute on chronic respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | View |
| Chronic obstructive airways disease exacerbated | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | View |
| Chronic obstructive pulmonary disease exacerbation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | View |
| Hypoxic respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | View |
| Pulmonary edema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | View |
| Pulmonary necrotizing granuloma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | View |
| Foot ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 24.0 | View |
| Acute limb ischemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 24.0 | View |
| Aortic stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 24.0 | View |
| Atherosclerosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 24.0 | View |
| Critical limb ischemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 24.0 | View |
| Hypertensive crisis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 24.0 | View |
| Hypertensive emergency | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 24.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 24.0 | View |
| Malignant hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 24.0 | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 24.0 | View |
Other Events(If Any):