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: 2025-12-25 @ 4:59 AM
Ignite Modification Date: 2025-12-26 @ 3:59 AM
NCT ID: NCT00705718
Description: Adverse events are submitted by the clinical study sites via electronic Case Report Form and are then reviewed by the sponsor.
Frequency Threshold: 5
Time Frame: 12 months
Study: NCT00705718
Study Brief: Endurant Bifurcated and Aorto-Uni-Iliac (AUI) Stent Graft System
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
1. Endurant AUI Arm Endurant Stent Graft System - Endurant AUI arm None None 25 44 35 44 View
2. Endurant Bifurcated Arm Endurant Stent Graft System - Endurant Bifurcated arm None None 64 150 80 150 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Other Complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Other Renal Complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Other Vascular Complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Increased Creatinine SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Other Bowel Complications SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Other Complications SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.0 View
Other Complications SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.0 View
Other Pulmonary Complication SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Other Orthopedic Complications SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Other Vascular Complications SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16.0 View
Lung Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16.0 View
Other Bowel Complications SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16.0 View
Other Renal Complications SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16.0 View
Cerebrovascular Accident (CVA) - Stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Intra-Cranial/Cerebral Hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Other Complications SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Other Neurological Complications SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Change In Mental Status SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16.0 View
Other Neurological Complications SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16.0 View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16.0 View
Other Renal Complications SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16.0 View
Other Urologic Complications SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16.0 View
Renal Artery Stenosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16.0 View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16.0 View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16.0 View
Other Vascular Complications SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 16.0 View
Acute Respiratory Distress Syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
COPD SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Other Bleeding Complications SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Other Complications SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Other Pulmonary Complication SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Pulmonary Embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Respiratory Depression or Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Shortness Of Breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Aneurysm Rupture SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Embolism (non-pulmonary) SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Other Cardiac Complications SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Other Vascular Complications SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Peripheral Ischemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Pseudoaneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Venous Insufficiency SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Vessel Rupture/Dissection (femoral, iliac, etc.) SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 16.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Wound Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Bleeding > 1000 cc, procedural SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Other Bleeding Complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Cardiopulmonary Failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Congestive Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
New Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Other Cardiac Complications SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Bowel Necrosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Bowel Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Diverticulitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Gastrointestinal Bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Intestinal Polyps SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Other Bleeding Complications SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Other Bowel Complications SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Other Complications SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Chest Pain, Non-Cardiac SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Death, Cause Unknown SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Endoleak Type IIa (single patent collateral vessel) SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Endoleak Type IIb (multiple patent collateral vessels) SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Endoleak Type Ib (Distal end) SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Multi-Organ Failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Other Complications SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Other Vascular Complications SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Stenosis SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Other Renal Complications SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Septic Shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Other Bowel Complications SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Other Complications SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 16.0 View
Other Bleeding Complications SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 16.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Other Complications SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 16.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 16.0 View
New Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Other Cardiac Complications SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Other Bowel Complications SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Fever SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Other Complications SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Wound Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.0 View
Other Wound Complications SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Seroma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.0 View
Low HCT/Low HGB SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Other Complications SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.0 View
Other Complications SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.0 View
Other Renal Complications SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.0 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Other Complications SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Other Complications SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Other Neurological Complications SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Other Complications SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16.0 View
Renal Insufficiency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16.0 View
Urinary Retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16.0 View
Other Pulmonary Complication SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.0 View
Other Complications SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16.0 View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.0 View