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 @ 1:34 AM
Ignite Modification Date: 2025-12-25 @ 11:48 PM
NCT ID: NCT00706394
Description: None
Frequency Threshold: 0
Time Frame: Up to 5 Years
Study: NCT00706394
Study Brief: 34mm Cuff Study for Endovascular Repair of Abdominal 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
Powerlink 34mm Cuff Stent Graft Powerlink 34mm cuff stent graft Endologix Powerlink 34 mm stent graft cuff used for Endovascular abdominal aortic aneurysm repair 6 None 14 19 7 19 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Custom Coding View
Decreased Hematocrit SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Custom Coding View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders Custom Coding View
Congestive Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders Custom Coding View
MI SYSTEMATIC_ASSESSMENT Cardiac disorders Custom Coding View
Triple Vessel Coronary Artery Disease SYSTEMATIC_ASSESSMENT Cardiac disorders Custom Coding View
Cholecystis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Custom Coding View
Erosive Gastritis/Epgastric Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Custom Coding View
GI Bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Custom Coding View
Gastroenteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Custom Coding View
Vomiting, Diarrhea, Dehydration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Custom Coding View
Increased Ascites secondary to cirrhosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Custom Coding View
Lieus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Custom Coding View
Pseudomembraneous colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Custom Coding View
Death SYSTEMATIC_ASSESSMENT General disorders Custom Coding View
Non cardiac CP SYSTEMATIC_ASSESSMENT General disorders Custom Coding View
Abdominal Pain SYSTEMATIC_ASSESSMENT General disorders Custom Coding View
Left groin incision infection SYSTEMATIC_ASSESSMENT Infections and infestations Custom Coding View
MRSA left lower leg SYSTEMATIC_ASSESSMENT Infections and infestations Custom Coding View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Custom Coding View
Compression Fracture of Lumbar Spine SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Custom Coding View
Umbilical Hernia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Custom Coding View
Brain Tumor SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Custom Coding View
Colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Custom Coding View
Metastatic Lung cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Custom Coding View
Metastatic Brain tumor SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Custom Coding View
Side branch-type pancreatic papillary mucinous neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Custom Coding View
Stage IV small cell lung cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Custom Coding View
Left lower lung mass SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Custom Coding View
Endoleak with Increased aneurysm SYSTEMATIC_ASSESSMENT Product Issues Custom Coding View
Limb extension right distal leak SYSTEMATIC_ASSESSMENT Product Issues Custom Coding View
Type I endoleak requiring endovascular repair SYSTEMATIC_ASSESSMENT Product Issues Custom Coding View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders Custom Coding View
Major depression recurrent SYSTEMATIC_ASSESSMENT Psychiatric disorders Custom Coding View
Acute renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders Custom Coding View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders Custom Coding View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders Custom Coding View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Custom Coding View
Right leg ulcer and tingling SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Custom Coding View
Translumbar embolization of AAA sac SYSTEMATIC_ASSESSMENT Surgical and medical procedures Custom Coding View
Aneurysm increased >/=5mm SYSTEMATIC_ASSESSMENT Vascular disorders Custom Coding View
Coagulopathy: decreased platelets due to HIT+ SYSTEMATIC_ASSESSMENT Vascular disorders Custom Coding View
Ischemic Left Leg SYSTEMATIC_ASSESSMENT Vascular disorders Custom Coding View
Left femoral-popliteal bypass with graft SYSTEMATIC_ASSESSMENT Vascular disorders Custom Coding View
Right femoral tibial bypass for gangrenous foot SYSTEMATIC_ASSESSMENT Vascular disorders Custom Coding View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Custom Coding View
Vision problems SYSTEMATIC_ASSESSMENT Eye disorders Custom Coding View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Custom Coding View
Postop ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Custom Coding View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Custom Coding View
Peri rectal abscess SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Custom Coding View
Burning down left anterior leg SYSTEMATIC_ASSESSMENT General disorders Custom Coding View
Chest pain SYSTEMATIC_ASSESSMENT General disorders Custom Coding View
Fatigue SYSTEMATIC_ASSESSMENT General disorders Custom Coding View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations Custom Coding View
Mild erythema left knee SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Custom Coding View
Right inguinal hernia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Custom Coding View
Endoleak Type I distal SYSTEMATIC_ASSESSMENT Product Issues Custom Coding View
Endoleak Type II IMA SYSTEMATIC_ASSESSMENT Product Issues Custom Coding View
Left distal endoleak SYSTEMATIC_ASSESSMENT Product Issues Custom Coding View
Type I endoleak SYSTEMATIC_ASSESSMENT Product Issues Custom Coding View
Type I endoleak - placement aortic stent SYSTEMATIC_ASSESSMENT Product Issues Custom Coding View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Custom Coding View
Lung nodule SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Custom Coding View
Pulmonary congestion postop SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Custom Coding View
Severe Pulmonary Enphisema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Custom Coding View
ABO Sugical Incisional Pain SYSTEMATIC_ASSESSMENT Surgical and medical procedures Custom Coding View
Incisional pain SYSTEMATIC_ASSESSMENT Surgical and medical procedures Custom Coding View
Left groin bleed SYSTEMATIC_ASSESSMENT Surgical and medical procedures Custom Coding View
Removal of sternal wire - non healing SYSTEMATIC_ASSESSMENT Surgical and medical procedures Custom Coding View
Carotid endoarterectomy SYSTEMATIC_ASSESSMENT Vascular disorders Custom Coding View
Carotid Stenosis SYSTEMATIC_ASSESSMENT Vascular disorders Custom Coding View
Elevated velocity left internal carotid SYSTEMATIC_ASSESSMENT Vascular disorders Custom Coding View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders Custom Coding View
Renal Artery stenosis SYSTEMATIC_ASSESSMENT Vascular disorders Custom Coding View
Increased Creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders Custom Coding View