Study: NCT00435942

Adverse event: Bleeding events
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 12 affected / 120 at risk

Adverse event: Cardiac complications
Serious: yes
Organ System: Cardiac disorders
Frequency: 21 affected / 120 at risk

Adverse event: Stent-graft endoleak
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 120 at risk

Adverse event: Hematology complications
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Includes anemia, coagulopathy, increased platelets
Frequency: 6 affected / 120 at risk

Adverse event: Neurological complications
Serious: yes
Organ System: Nervous system disorders
Notes: Includes stroke, paraplegia, paraparesis
Frequency: 19 affected / 120 at risk

Adverse event: Pulmonary Complications
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 120 at risk

Adverse event: Renal/genitourinary complications
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 12 affected / 120 at risk

Adverse event: Vascular complications
Serious: yes
Organ System: Vascular disorders
Notes: Includes ruptures of untreated aneurysms, aortic dissecton
Frequency: 10 affected / 120 at risk

Adverse event: Vascular access complications
Serious: yes
Organ System: Vascular disorders
Notes: includes access difficulty, iliac artery injury
Frequency: 4 affected / 120 at risk

Adverse event: General
Serious: yes
Organ System: General disorders
Notes: includes a variety of event types (e.g., decreased nutritional intake, volume overload, etc.)
Frequency: 15 affected / 120 at risk

Adverse event: Neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 120 at risk

Adverse event: Digestive/gastrointestinal complications
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 120 at risk

Adverse event: Dermatological complications
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Device malfunctions
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 120 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 120 at risk

Adverse event: Bleeding Events
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Includes procedural bleeding and post-procedural bleeding
Frequency: 22 affected / 120 at risk

Adverse event: Cardiac complications
Serious: no
Organ System: Cardiac disorders
Frequency: 35 affected / 120 at risk

Adverse event: Stent-graft endoleak
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 14 affected / 120 at risk

Adverse event: Hematology complications
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Includes anemia, coagulopathy, thrombocytopenia
Frequency: 28 affected / 120 at risk

Adverse event: Neurological complications
Serious: no
Organ System: Nervous system disorders
Frequency: 39 affected / 120 at risk

Adverse event: Pulmonary complications
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 120 at risk

Adverse event: Renal/genitourinary complications
Serious: no
Organ System: Renal and urinary disorders
Frequency: 24 affected / 120 at risk

Adverse event: Vascular complications
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 120 at risk

Adverse event: Vascular Access Complications
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 120 at risk

Adverse event: General
Serious: no
Organ System: General disorders
Frequency: 55 affected / 120 at risk

Adverse event: Neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 120 at risk

Adverse event: Digestive/gastrointestinal complications
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 120 at risk

Adverse event: Dermatological Complications
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 120 at risk

Adverse event: Device Malfunctions
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 120 at risk

Adverse event: Localized pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 23 affected / 120 at risk

Adverse event: Hepatic complications
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 120 at risk

Adverse event: Bleeding events
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 33 affected / 60 at risk

Adverse event: Cardiac complications
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 60 at risk

Adverse event: Hematology complications
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Includes anemia, coagulopathy, increased platelets
Frequency: 3 affected / 60 at risk

Adverse event: Neurological complications
Serious: yes
Organ System: Nervous system disorders
Notes: Includes stroke, paraplegia, paraparesis
Frequency: 8 affected / 60 at risk

Adverse event: Pulmonary Complications
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 60 at risk

Adverse event: Renal/genitourinary complications
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 60 at risk

Adverse event: Vascular complications
Serious: yes
Organ System: Vascular disorders
Notes: Includes ruptures of untreated aneurysms, aortic dissecton
Frequency: 5 affected / 60 at risk

Adverse event: General
Serious: yes
Organ System: General disorders
Notes: includes a variety of event types (e.g., decreased nutritional intake, volume overload, etc.)
Frequency: 7 affected / 60 at risk

Adverse event: Neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 60 at risk

Adverse event: Digestive/gastrointestinal complications
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 60 at risk

Adverse event: Device malfunctions
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 60 at risk

Adverse event: Bleeding Events
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Includes procedural bleeding and post-procedural bleeding
Frequency: 25 affected / 60 at risk

Adverse event: Cardiac complications
Serious: no
Organ System: Cardiac disorders
Frequency: 27 affected / 60 at risk

Adverse event: Hematology complications
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Includes anemia, coagulopathy, thrombocytopenia
Frequency: 19 affected / 60 at risk

Adverse event: Neurological complications
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 60 at risk

Adverse event: Pulmonary complications
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 35 affected / 60 at risk

Adverse event: Renal/genitourinary complications
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 60 at risk

Adverse event: Vascular complications
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 60 at risk

Adverse event: General
Serious: no
Organ System: General disorders
Frequency: 31 affected / 60 at risk

Adverse event: Neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 60 at risk

Adverse event: Digestive/gastrointestinal complications
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 60 at risk

Adverse event: Dermatological Complications
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 60 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 60 at risk

Adverse event: Localized pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 60 at risk