Study: NCT00068107

Adverse event: catheter-induced peritonitis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 13 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk

Adverse event: advanced renal insufficiency
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 13 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk

Adverse event: Sharp chest pain and right leg pain
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: syncopal episode
Serious: yes
Organ System: Cardiac disorders
Notes: occurred while straining when lifting weight in a gym
Frequency: 1 affected / 13 at risk

Adverse event: Vomiting
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pain
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: elective mitral valve annuloplasty
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk

Adverse event: increased intensity of angina
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk

Adverse event: Bacterial sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: recurrent ventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk

Adverse event: hepatitis C infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Aortic valve replacement
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk

Adverse event: dizziness, tachycardia and chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk

Adverse event: severe renal decline
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 13 at risk

Adverse event: clogged port-a-cath replacement and pacemaker adjustment
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk

Adverse event: placement of a pacemaker due to a bradycardic episode
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk

Adverse event: acute occipital ischemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk

Adverse event: Allergies
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 13 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 13 at risk

Adverse event: Arrythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 13 at risk

Adverse event: Impaired balance
Serious: no
Organ System: General disorders
Frequency: 2 affected / 13 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 13 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Cancer - skin
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 13 at risk

Adverse event: Cardiac palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk

Adverse event: Cholethisiasis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 13 at risk

Adverse event: Creatinine worsened
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 13 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 13 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Dialysis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 13 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Dreams (abnormal)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Ecchymosis - varied
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Oedema
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 13 at risk

Adverse event: Eosinophils - increased
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Electrolytes - elevated
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 13 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Ferritin - decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Ferritin - increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 13 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 13 at risk

Adverse event: GI symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 13 at risk

Adverse event: Glucose - elevated
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Alopecia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 13 at risk

Adverse event: Deafness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 13 at risk

Adverse event: Atrioventricular block
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 13 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 13 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 13 at risk

Adverse event: Hypothyroid
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 13 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 13 at risk

Adverse event: Injury - trauma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 13 at risk

Adverse event: Iron - decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Kidney nodules/cysts
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 13 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Memory - decreased
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Mental status altered
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Microalbuminuria - worsened
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 13 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Orthopedic
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pain - back
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pain - chest (no specific angina)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 13 at risk

Adverse event: Pain - finger
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pain - GI
Serious: no
Organ System: General disorders
Frequency: 2 affected / 13 at risk

Adverse event: Pain - knee
Serious: no
Organ System: General disorders
Frequency: 2 affected / 13 at risk

Adverse event: Pain - leg (spastic)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pain - neck area
Serious: no
Organ System: General disorders
Frequency: 2 affected / 13 at risk

Adverse event: Pain - pelvic area
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pain - shoulder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Potassium - elevated
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 13 at risk

Adverse event: Proteinuria - increased
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 13 at risk

Adverse event: Benign prostatic hyperplasia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 13 at risk

Adverse event: Prostatitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 13 at risk

Adverse event: PSA - elevated
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 13 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 13 at risk

Adverse event: Restless legs syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 13 at risk

Adverse event: Sodium - elevated
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Speech - impaired
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Stool leakage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Stroke - acute ischemic
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Throat - dry
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Transplant - kidney
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 13 at risk

Adverse event: Tremors
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: TSH - elevated
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 13 at risk

Adverse event: Urine - bloody s/p prostate biopsy
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 13 at risk

Adverse event: Virus - post transplant
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Vision - hazy
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 13 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Weight loss - unexpected
Serious: no
Organ System: General disorders
Frequency: 2 affected / 13 at risk