Study: NCT00366249

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 553 at risk

Adverse event: Abscess
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 553 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 553 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 553 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 553 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 553 at risk

Adverse event: Gangrene
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 553 at risk

Adverse event: Infection
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 553 at risk

Adverse event: Sepsis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 553 at risk

Adverse event: Septic shock
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 553 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 553 at risk

Adverse event: Arterial thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 553 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 553 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 553 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 553 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 553 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 553 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 553 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 553 at risk

Adverse event: Vascular occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 553 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 553 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 553 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 553 at risk

Adverse event: Shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 553 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 553 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 553 at risk

Adverse event: Vasculitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 553 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 553 at risk

Adverse event: Hepatic cirrhosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 553 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 553 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 553 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 553 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 553 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 553 at risk

Adverse event: Liver injury
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 553 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 553 at risk

Adverse event: Gastric atony
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 553 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 553 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 553 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 553 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 553 at risk

Adverse event: Impaired healing
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 553 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 553 at risk

Adverse event: Lipase increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 553 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 553 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 553 at risk

Adverse event: Arthritis bacterial
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 553 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 553 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 553 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 553 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 553 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 553 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 553 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 553 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 553 at risk

Adverse event: Skin necrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 553 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 553 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 553 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 553 at risk

Adverse event: Left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 553 at risk

Adverse event: Vascular disorder general
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 553 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 20 affected / 553 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 19 affected / 553 at risk

Adverse event: Respiratory system general
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 32 affected / 553 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 27 affected / 553 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 26 affected / 553 at risk

Adverse event: Skin and appendages general
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 43 affected / 553 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 25 affected / 553 at risk

Adverse event: Urogenital general
Serious: no
Organ System: Renal and urinary disorders
Frequency: 24 affected / 553 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 36 affected / 553 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 75 affected / 553 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 553 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 227 affected / 553 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 151 affected / 553 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 553 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 50 affected / 553 at risk

Adverse event: Serum glutamic oxaloacetic transaminase (SGOT) increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 553 at risk

Adverse event: Serum glutamic pyruvic transaminase (SGPT) increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 553 at risk

Adverse event: Osteomyelitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 25 affected / 553 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 553 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 553 at risk

Adverse event: Infection
Serious: no
Organ System: General disorders
Frequency: 12 affected / 553 at risk

Adverse event: Injury
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 508 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 508 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 508 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 508 at risk

Adverse event: Gangrene
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 508 at risk

Adverse event: Infection
Serious: yes
Organ System: General disorders
Frequency: 16 affected / 508 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 508 at risk

Adverse event: Sepsis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 508 at risk

Adverse event: Arterial thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 508 at risk

Adverse event: Bundle branch block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 508 at risk

Adverse event: Cardiomegaly
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 508 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 508 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 508 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 508 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 508 at risk

Adverse event: Vascular occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 508 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 508 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 508 at risk

Adverse event: Thrombophlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 508 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 508 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 508 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 508 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 508 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 508 at risk

Adverse event: Impaired healing
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 508 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 508 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 508 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 508 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 508 at risk

Adverse event: Hallucination
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 508 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 508 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 508 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 508 at risk

Adverse event: Stupor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 508 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 508 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 508 at risk

Adverse event: Pleuritic pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 508 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 508 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 508 at risk

Adverse event: Skin necrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 508 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 508 at risk

Adverse event: Dermatitis bullous
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 508 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 508 at risk

Adverse event: Local reaction to procedure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 508 at risk

Adverse event: Vascular disorder general
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 508 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 11 affected / 508 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 508 at risk

Adverse event: Respiratory system general
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 29 affected / 508 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 19 affected / 508 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 20 affected / 508 at risk

Adverse event: Skin and appendages general
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 28 affected / 508 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 17 affected / 508 at risk

Adverse event: Urogenital general
Serious: no
Organ System: Renal and urinary disorders
Frequency: 27 affected / 508 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 40 affected / 508 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 51 affected / 508 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 508 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 508 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 508 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 508 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 508 at risk

Adverse event: Serum glutamic oxaloacetic transaminase (SGOT) increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 508 at risk

Adverse event: Serum glutamic pyruvic transaminase (SGPT) increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 508 at risk

Adverse event: Osteomyelitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 508 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 508 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 508 at risk

Adverse event: Infection
Serious: no
Organ System: General disorders
Frequency: 19 affected / 508 at risk