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 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
NCT ID:
NCT01173718
Description:
None
Frequency Threshold:
5.0
Time Frame:
None
Study:
NCT01173718
Study Brief:
Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access
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® ACUSEAL Vascular Graft | GORE® ACUSEAL Vascular Graft | None | None | 74 | 138 | 0 | 138 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Septicemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Staphylococcal bacteremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Staphylococcus aureus bacteremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Staphylococcus epidermidis infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Urinary tract infection pseudomonal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Wound infection due to staphylococcus aureus | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Anastomotic ulcer hemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 13.1 | View |
| Arteriovenous graft site hemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 13.1 | View |
| Bleeding of suture site | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 13.1 | View |
| Burst fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 13.1 | View |
| Suture related complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 13.1 | View |
| Wrist fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 13.1 | View |
| Pulseless | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 13.1 | View |
| Acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Failure to thrive | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Hyperkalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Hypoglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Volume overload | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 13.1 | View |
| Hand pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | View |
| Breast cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | View |
| Colonic neoplasm NOS | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | View |
| Gastrointestinal stromal tumor | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | View |
| Malignant neoplasm of pleura | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | View |
| Multiple myeloma progression | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | View |
| Non-small cell lung cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | View |
| Rectal adenocarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | View |
| Anoxic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 13.1 | View |
| CVA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 13.1 | View |
| Carotid artery stenosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 13.1 | View |
| Encephalopathy acute | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 13.1 | View |
| Ischemic neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 13.1 | View |
| Stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 13.1 | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 13.1 | View |
| Acute confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 13.1 | View |
| Mental status changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 13.1 | View |
| End stage renal disease (ESRD) | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 13.1 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 13.1 | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Aspiration pneumonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Hypercapnic respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Pulmonary hypertension | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Pulmonary mass | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Respiratory distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Shortness of breath | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
| Renal transplant | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA Version 13.1 | View |
| Critical limb ischemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 13.1 | View |
| Embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 13.1 | View |
| Hypertension worsened | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 13.1 | View |
| Hypertensive crisis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 13.1 | View |
| Hypertensive urgency | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 13.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 13.1 | View |
| Peripheral ischemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 13.1 | View |
| Peripheral vascular disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 13.1 | View |
| Steal syndrome | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 13.1 | View |
| Uncontrolled hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 13.1 | View |
| Appendicitis perforated | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Arteriovenous graft site cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Arteriovenous graft site infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Bacterial endocarditis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Cellulitis of hand | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Clostridium difficile colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Community acquired pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Enterococcal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Graft infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Incision site infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 13.1 | View |
| Chronic thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 13.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 13.1 | View |
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Atrial tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Cardiopulmonary arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Non ST segment elevation myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Non STEMI | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Pulseless electrical activity | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| STEMI | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| SVT | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Unstable angina | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Polycystic kidney | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA Version 13.1 | View |
| Diabetic gastroparesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| GI bleed | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Gastric polyps | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Gastrointestinal bleed | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Gastroparesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Rectal bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Edema face | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 13.1 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 13.1 | View |
| Liver failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA Version 13.1 | View |
| Anemia aggravated | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 13.1 | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 13.1 | View |
| Acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Atrial fibrillation with rapid ventricular response | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Cardiac arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Cardiogenic shock | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Chest pain - cardiac | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Congestive heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Diastolic heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Non-sustained ventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 13.1 | View |
| Erosive esophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Ileitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Large intestine mass | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Peptic ulcer disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 13.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 13.1 | View |
| Edema extremity upper | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 13.1 | View |
| Multi organ failure | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 13.1 | View |
| Swelling arm | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 13.1 | View |
| Hematoma infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Infected toe | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Peripheral gangrene | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 13.1 | View |
| Pancreatic cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | View |
| Prostate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | View |
Other Events(If Any):