Study: NCT01921218

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: secondary to failing graft and end stage renal disease (ESRD)
Frequency: 1 affected / 6 at risk

Adverse event: Groin abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Initiation of hemodialysis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 6 at risk

Adverse event: Deep vein thrombosis and pulmonary embolism
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Peritoneal dialysis catheter blockage or malfunction
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 6 at risk

Adverse event: Exacerbation of hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 6 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pneumonia related to H1N1 influenza culminating in death
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Malfunctionig arteriovenous (AV) fistula with edema
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 6 at risk

Adverse event: Increased creatinine
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 6 at risk

Adverse event: Escherichia coli urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pulmonary edema, grade 1
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Fatigue, grade 1
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Fatigue, grade 2
Serious: no
Organ System: General disorders
Frequency: 3 affected / 6 at risk

Adverse event: Nausea, grade 1
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Abdominal cramps, grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhea, grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 6 at risk

Adverse event: Diarrhea, grade 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 6 at risk

Adverse event: Arthralgia, grade 2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Arthralgia, grade 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 6 at risk

Adverse event: Left leg cramps, grade 2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypoglycemia, grade 2
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 6 at risk

Adverse event: Bilateral feet cramps, grade 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Peritonitis, grade 2
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 6 at risk

Adverse event: Bilateral restless legs, grade 1
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Forgetfulness, grade 1
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Disc protrusion, grade 2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Facet joint hypertrophy, grade 2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypertension, grade 3
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 6 at risk

Adverse event: Nervousness, grade 1
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Lesion on upper palate, grade 1
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Upper respiratory infection, grade 2
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 6 at risk

Adverse event: Upper respiratory infection, grade 1
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Tendonitis bilateral ankles, grade 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 6 at risk

Adverse event: Chest pain, grade 3
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Chest pain, grade 1
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pruritus, grade 2
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 6 at risk

Adverse event: Hypocalcemia, grade 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Abdominal pain, grade 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Knee meniscus tear, grade 2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Osteoarthritis in knee, grade 2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Fractured toes due to motor vehicle accident, grade 2
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk

Adverse event: Leg pain possibly due to sciatica, grade 2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 6 at risk

Adverse event: Benign right ovarian cysts, grade 1
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 6 at risk

Adverse event: Urinary tract infection with bacteremia, grade 3
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Atrial flutter, grade 1
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Squamous cell carcinoma, grades 1 and 2
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 6 at risk

Adverse event: Anxiety, grade 1
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 6 at risk

Adverse event: Peritoneal dialysis site infection, grade 2
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Coughing and wheezing, grade 2
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Exacerbation of gout, grades 2 and 3
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 6 at risk

Adverse event: Multiple non-malignant skin lesions, grade 1
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 6 at risk

Adverse event: Influenza A and B, grade 2
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Pneumonia, grade 2
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Burst bursa sac after fall, grade 2
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk

Adverse event: Atrial fibrillation, grade 1
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Nausea, grade 3
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Vomiting, grade 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Vomiting, grade 3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhea, grade 3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Lower extremity edema, grade 1
Serious: no
Organ System: General disorders
Frequency: 4 affected / 6 at risk

Adverse event: Hyperkalemia, grade 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Indigestion, grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Right clogged ear, grade 1
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hyperphosphatemia, grade 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypotension, grade 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Shortness of breath, grade 1
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Headache, grade 1
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hot flashes, grade 1
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Intermittent bone pain, grade 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Intermittent jaw pain, grade 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Chest wall pain at site of dialysis catheter, grade 1
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 6 at risk

Adverse event: Scapular pain, grade 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Chronic pulmonary embolus, grade 2
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Intermittent hand cramping, grade 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Muscle aches, grade 2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hyperparathyroidism, grade 2
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 6 at risk

Adverse event: Asymmetry in right breast, grade 1
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hives bilateral lower leg, grade 1
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Sinus congestion, grade 1
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Intermittent bilateral foot swelling, grade 1
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Generalized urticaria, grade 1
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Lip sore, grade 1
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Scleral redness, grade 1
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 6 at risk

Adverse event: Lower extremity weakness, grade 2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Lower spine pain, grade 2
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypokalemia, grade 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Urinary tract infection, grade 2
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Shoulder pain, grade 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 6 at risk

Adverse event: Foot pain, grade 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dry cough, grade 1
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Perihepatic ascites, grade 1
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Weight loss, grade 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Bilateral hip edema, grade 1
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Sigmoid diverticulosis, grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Exacerbation of anemia, grade 1
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Altered mental status, grade 3
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypoglycemia, grade 3
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 6 at risk

Adverse event: Pressure ulcers on sacrum and coccyx, grade 3
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Weakness, grade 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Shaking, grade 1
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Peritoneal catheter removal, grade 1
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Exacerbation of insomnia, grade 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Weight gain, grade 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypertension exacerbation, grade 1
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 6 at risk

Adverse event: Lesions removed from arm, grade 2
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 6 at risk

Adverse event: Peritoneal dialysis catheter blockage or malfunction
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 7 at risk

Adverse event: Acute rejection
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 7 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 7 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Peritonitis with sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Hypertensive crisis with seizure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: secondary to fatal arrythmia in the setting of ESRD
Frequency: 1 affected / 7 at risk

Adverse event: Infected permacath
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Acute respiratory failure with hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Posterior reversible encephalopathy syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Nausea, grade 1
Serious: no
Organ System: General disorders
Frequency: 2 affected / 7 at risk

Adverse event: Diarrhea, grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 7 at risk

Adverse event: Diarrhea, grade 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 7 at risk

Adverse event: Peritonitis, grade 2
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 7 at risk

Adverse event: Hypertension, grade 3
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 7 at risk

Adverse event: Chest pain, grade 1
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 7 at risk

Adverse event: Sycopal episode, grade 3
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Graft tenderness, grade 1
Serious: no
Organ System: General disorders
Frequency: 2 affected / 7 at risk

Adverse event: Hematuria, grade 1
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 7 at risk

Adverse event: Posterior reversible encephalopathy, grade 3
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Peritoneal dialysis catheter malfunction, grade 3
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 7 at risk

Adverse event: Exacerbation of baseline anemia, grade 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Atrial fibrillation, grade 1
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 7 at risk

Adverse event: Pericardial effusion, grade 3
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Shingles, grade 1
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 7 at risk

Adverse event: Pneumonia, grade 3
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Colitis, grade 3
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Cellulitis, grade 2
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Otitis media, grade 2
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 5 affected / 7 at risk

Adverse event: Acute pharyngitis, grade 2
Serious: no
Organ System: General disorders
Frequency: 2 affected / 7 at risk

Adverse event: Eustacian tube dysfunction, grade 2
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 7 at risk

Adverse event: Sinusitis, grade 2
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Rise in creatinine, grade 2
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: Viral syndrome, grade 2
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Keratitis dendritic herpes, grade 2
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hypotension, grade 1
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 7 at risk

Adverse event: Febrile illness, grade 1
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 7 at risk

Adverse event: Shin injury, grade 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Cold sensitivity, grade 1
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Vomiting, grade 2
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hypertensive crisis, grade 2
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 7 at risk

Adverse event: Syncopal episode, grade 3
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Fever, grade 2
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hypervolemia, grade 1
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Joint pain, grade 1
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Enlarged axillary lymph node, grade 1
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Pyelonephritis, grade 1
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hypokalemia, grade 1
Serious: no
Organ System: General disorders
Frequency: 2 affected / 7 at risk

Adverse event: Dizziness, grade 1
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Diaphoresis, grade 1
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Peritonitis, grade 1
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Internal hemorrhoids, grade 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Knee replacement, grade 2
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 7 at risk

Adverse event: Knee drainage, grade 1
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 7 at risk

Adverse event: Lower extremity swelling, grade 1
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Aortic stenosis, grade 2
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: Serratia bacteremia, grade 2
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Metatarsal fracture, grade 2
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 7 at risk