Study: NCT01049919

Adverse event: Major Amputation - Index Leg
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 19 affected / 119 at risk

Adverse event: Pain - Index Leg
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 119 at risk

Adverse event: Cellulitis - Index Leg
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 119 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 119 at risk

Adverse event: Ischemia - Index Leg
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 119 at risk

Adverse event: Toe Amputation - Index Leg
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 119 at risk

Adverse event: Gangrene - Index Leg
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 119 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 119 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Acute Congestive Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 119 at risk

Adverse event: Wound - Index Leg
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 119 at risk

Adverse event: Infection - Index Leg
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 119 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 119 at risk

Adverse event: Bypass Graft - Index Leg
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 119 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 119 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Low Red Blood Cell-Related Level
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 119 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 119 at risk

Adverse event: Osteomyelitis - Index Leg
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 119 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 119 at risk

Adverse event: Wound - Contralateral Leg
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 119 at risk

Adverse event: Ischemic Bowel
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 119 at risk

Adverse event: Nausea/Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 119 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 119 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 119 at risk

Adverse event: Abdominal Sepsis/Shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 119 at risk

Adverse event: Abscess - Buttock
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 119 at risk

Adverse event: Angioplasty - Contralateral Leg
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 119 at risk

Adverse event: Angioplasty - Index Leg
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 119 at risk

Adverse event: Asystole Episode
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 119 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 119 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 119 at risk

Adverse event: Cardiac Decompensation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 119 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 119 at risk

Adverse event: Carotid Blockage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 119 at risk

Adverse event: Cellulitis - Arm
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 119 at risk

Adverse event: Cellulitis - Bilateral Legs
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 119 at risk

Adverse event: Cellulitis - Contralateral Leg
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 119 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 119 at risk

Adverse event: Deep Vein Thrombosis - Index Leg
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 119 at risk

Adverse event: Deconditioning
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 119 at risk

Adverse event: Degenerative Disc - Cervical Spine
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 119 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 119 at risk

Adverse event: Elective surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 119 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 119 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 119 at risk

Adverse event: Fracture - Contralateral Leg
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 119 at risk

Adverse event: Haematoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 119 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 119 at risk

Adverse event: Ileocolic Anastomotic Leak
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Infected Abdominal Mesh
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 119 at risk

Adverse event: Infection - Contralateral Leg
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 119 at risk

Adverse event: Abdominal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 119 at risk

Adverse event: Knee Revision - Index Leg
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 119 at risk

Adverse event: Large intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 119 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 119 at risk

Adverse event: Menstruation
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 119 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 119 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 119 at risk

Adverse event: Non-Healing of Toe Amputation Site
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Osteomyelitis - Contralateral Leg
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 119 at risk

Adverse event: Sedation complication
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 119 at risk

Adverse event: Pain - Contralateral Leg
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 119 at risk

Adverse event: Peripheral Artery Disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 119 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 119 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 119 at risk

Adverse event: Superior Mesenteric Artery Thrombus
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 119 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 119 at risk

Adverse event: Stenosis of Bypass Graft - Index Leg
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 119 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 119 at risk

Adverse event: Syncope
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 119 at risk

Adverse event: Ulceration - Contralateral Leg
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 119 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 119 at risk

Adverse event: Venous Thromboembolism - Contralateral Leg
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 119 at risk

Adverse event: Low Red Blood Cell-Related Level
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 87 affected / 119 at risk

Adverse event: Pain - Index Leg
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 62 affected / 119 at risk

Adverse event: Pain - Bilateral Iliac Crests
Serious: no
Organ System: General disorders
Notes: Pain from bone marrow aspiration procedure.
Frequency: 30 affected / 119 at risk

Adverse event: Ulceration - Index Leg
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 119 at risk

Adverse event: Low White Blood Cell-Related Level
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 119 at risk

Adverse event: Cellulitis - Index Leg
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 119 at risk

Adverse event: Erythema - Index Leg
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 119 at risk

Adverse event: Edema - Index Leg
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 119 at risk

Adverse event: High White Blood Cell-Related Level
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 119 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 119 at risk

Adverse event: Pain - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 119 at risk

Adverse event: Wound - Index Leg
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 119 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 119 at risk

Adverse event: Gangrene - Index Leg
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dry gangrene
Frequency: 9 affected / 119 at risk

Adverse event: Infection - Index Leg
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 119 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 119 at risk

Adverse event: High Red Blood Cell-Related Level
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 119 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 119 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 119 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 119 at risk

Adverse event: Acute Congestive Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 119 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 119 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 119 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 119 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 119 at risk

Adverse event: Bypass Graft - Index Leg
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 119 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 119 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 119 at risk

Adverse event: Fissure - Index Leg
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 119 at risk

Adverse event: Numbness - Index Leg
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 119 at risk

Adverse event: Pain - Hip
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 119 at risk

Adverse event: Major Amputation - Index Leg
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 8 affected / 36 at risk

Adverse event: Pain - Index Leg
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 36 at risk

Adverse event: Cellulitis - Index Leg
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 36 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 36 at risk

Adverse event: Ischemia - Index Leg
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 36 at risk

Adverse event: Toe Amputation - Index Leg
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 36 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 36 at risk

Adverse event: Acute Congestive Heart Failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 36 at risk

Adverse event: Wound - Index Leg
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 36 at risk

Adverse event: Bypass Graft - Index Leg
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 36 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 36 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 36 at risk

Adverse event: Low Red Blood Cell-Related Level
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 36 at risk

Adverse event: Ulceration - Index Leg
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 36 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Wound - Contralateral Leg
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Amputation of Foot - Contralateral Foot
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 36 at risk

Adverse event: Amputation of Toe - Contralateral Leg
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 36 at risk

Adverse event: Anaphylaxis Related to Antibiotic
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 36 at risk

Adverse event: Blood loss anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 36 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 36 at risk

Adverse event: Major Amputation - Contralateral Leg
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 36 at risk

Adverse event: Non-ST-Elevation Myocardial Infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 36 at risk

Adverse event: Shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 36 at risk

Adverse event: General Weakness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 36 at risk

Adverse event: Weakness - Hand
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 36 at risk

Adverse event: Low Red Blood Cell-Related Level
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 36 at risk

Adverse event: Pain - Index Leg
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 36 at risk

Adverse event: Pain - Bilateral Iliac Crests
Serious: no
Organ System: General disorders
Notes: Pain from bone marrow aspiration procedure.
Frequency: 4 affected / 36 at risk

Adverse event: Ulceration - Index Leg
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 36 at risk

Adverse event: Low White Blood Cell-Related Level
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 36 at risk

Adverse event: Cellulitis - Index Leg
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 36 at risk

Adverse event: Erythema - Index Leg
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 36 at risk

Adverse event: Edema - Index Leg
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 36 at risk

Adverse event: High White Blood Cell-Related Level
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 36 at risk

Adverse event: Pain - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 36 at risk

Adverse event: Wound - Index Leg
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 36 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 36 at risk

Adverse event: Gangrene - Index Leg
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Dry gangrene
Frequency: 1 affected / 36 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 36 at risk

Adverse event: High Red Blood Cell-Related Level
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 36 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 36 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 36 at risk

Adverse event: Acute Congestive Heart Failure
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 36 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 36 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Bypass Graft - Index Leg
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 36 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 36 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 36 at risk

Adverse event: Fissure - Index Leg
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 36 at risk

Adverse event: Numbness - Index Leg
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 36 at risk

Adverse event: Pain - Hip
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 36 at risk

Adverse event: Pruritis - Index Leg
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 36 at risk