Study: NCT01941030

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 25 at risk

Adverse event: Cellulitis, index limb
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 25 at risk

Adverse event: Coronary Artery disease, worsening
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk

Adverse event: Death, cardiac
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk

Adverse event: Death, unknown cause
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 25 at risk

Adverse event: Dissection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 25 at risk

Adverse event: GI bleeding
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Major amputation, index limb, due to infected knee replacement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 25 at risk

Adverse event: Major amputation, index limb due to gangrene
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 25 at risk

Adverse event: Major amputation, index limb due to osteomyelitis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 25 at risk

Adverse event: Minor amputation - pre-planned, index limb
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 25 at risk

Adverse event: Minor amputation, index limb due to gangrene
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 25 at risk

Adverse event: Minor amputation, index limb due to osteomyelitis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 25 at risk

Adverse event: Minor amputation, non-index limb due to gangrene
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 25 at risk

Adverse event: Minor amputation, non-index limb due to osteomyelitis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 25 at risk

Adverse event: Other - Syncope
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Revascularization - pre-planned, non-index limb
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 25 at risk

Adverse event: Revascularization, index limb (non-TVR)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 25 at risk

Adverse event: Revascularization, index limb (TLR)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 25 at risk

Adverse event: Revascularization, non-index limb
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 25 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk

Adverse event: Worsening of index wound
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 25 at risk

Adverse event: Dissection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 25 at risk

Adverse event: Vessel spasm
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 25 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: Cellulitis, index limb
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 26 at risk

Adverse event: Coronary Artery disease, worsening
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 26 at risk

Adverse event: Deep Vein Thrombosis, upper arm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 26 at risk

Adverse event: Death, non-cardiac
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 26 at risk

Adverse event: Death, unknown cause
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Distal embolization
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 26 at risk

Adverse event: Hernia repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 26 at risk

Adverse event: Infection, other
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 26 at risk

Adverse event: Major amputation, index limb due to gangrene
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 26 at risk

Adverse event: Medication overdose
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Medication side effect
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Minor amputation - pre-planned, index limb
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 26 at risk

Adverse event: Minor amputation, index limb due to gangrene
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 26 at risk

Adverse event: Minor amputation, index limb due to osteomyelitis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 26 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 26 at risk

Adverse event: Osteomyelitis, index limb
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 26 at risk

Adverse event: Osteomyelitis, non-index limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 26 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Recoil
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 26 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 26 at risk

Adverse event: Revascularization - pre-planned, non-index limb
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 26 at risk

Adverse event: Revascularization, index limb (non-TVR)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 26 at risk

Adverse event: Revascularization, index limb (TLR)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 26 at risk

Adverse event: Revascularization, non-index limb
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 26 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 26 at risk

Adverse event: Access site bleeding
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 26 at risk

Adverse event: Dissection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 26 at risk

Adverse event: Lower extremity edema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pseudoaneurysm, access site
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 26 at risk

Adverse event: Slow flow
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 26 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 26 at risk