Study: NCT01628120

Adverse event: Blood loss anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 170 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 170 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 170 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 170 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 170 at risk

Adverse event: Bundle branch block left
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 170 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 170 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 170 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 170 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 170 at risk

Adverse event: Mitral valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 170 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 170 at risk

Adverse event: Nodal rhythm
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 170 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 170 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 170 at risk

Adverse event: Optic neuropathy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 170 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 170 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 170 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 170 at risk

Adverse event: Diabetic gastroparesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 170 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Oesophagitis ulcerative
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 170 at risk

Adverse event: Rectal fissure
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 170 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 170 at risk

Adverse event: Appendicitis perforated
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 170 at risk

Adverse event: Arteriovenous graft site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 170 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 170 at risk

Adverse event: Enterococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 170 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 170 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 170 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 170 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 170 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 170 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 170 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 170 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 170 at risk

Adverse event: Streptococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 170 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 170 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 170 at risk

Adverse event: Arteriovenous fistula site haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 170 at risk

Adverse event: Arteriovenous fistula thrombosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 170 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 170 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 170 at risk

Adverse event: Vascular graft complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 170 at risk

Adverse event: Vascular graft thrombosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 170 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 170 at risk

Adverse event: Calciphylaxis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 170 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 170 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 170 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 170 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 170 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 170 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 170 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 170 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 170 at risk

Adverse event: Bladder neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 170 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: This is a gender specific event.
Frequency: 1 affected / 75 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 170 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 170 at risk

Adverse event: Hypoxic-ischaemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 170 at risk

Adverse event: Metabolic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 170 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 170 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 170 at risk

Adverse event: Facial paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 170 at risk

Adverse event: Azotaemia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 170 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 170 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 170 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Bronchitis chronic
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 170 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 170 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 170 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 170 at risk

Adverse event: Hyperkeratosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 170 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 170 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 170 at risk

Adverse event: Peripheral vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 170 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 27 affected / 170 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 170 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 170 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 170 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 170 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 170 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 170 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 17 affected / 170 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 170 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 170 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 170 at risk

Adverse event: Arteriovenous fistula site complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 170 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 170 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 170 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 170 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 170 at risk

Adverse event: Vascular graft complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 170 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 170 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 170 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 170 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 9 affected / 170 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 170 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 170 at risk

Adverse event: Arteriovenous fistula thrombosis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 170 at risk