Study: NCT01972035

Adverse event: Acute Kidney Problems
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 66 at risk

Adverse event: Ascites
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 66 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 66 at risk

Adverse event: Biopsy
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 66 at risk

Adverse event: Blood sugar concerns
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 66 at risk

Adverse event: Breathing concerns
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 66 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 66 at risk

Adverse event: Donor source antibodies
Serious: yes
Organ System: Immune system disorders
Frequency: 4 affected / 66 at risk

Adverse event: Elevated Creatinine
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 21 affected / 66 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Immune system disorders
Frequency: 7 affected / 66 at risk

Adverse event: G Tube Concerns
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 66 at risk

Adverse event: Heart concerns
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 66 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 66 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 66 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 66 at risk

Adverse event: Severe Pain
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 66 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 66 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Immune system disorders
Frequency: 7 affected / 66 at risk

Adverse event: Urination Concerns
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 66 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 66 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 66 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 66 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 43 affected / 66 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 66 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 66 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 66 at risk

Adverse event: Alopecia
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 66 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 64 affected / 66 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 66 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 40 affected / 66 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 6 affected / 66 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 66 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 66 at risk

Adverse event: Acute Kidney Problems
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 71 at risk

Adverse event: Ascites
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 71 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 71 at risk

Adverse event: Biopsy
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 71 at risk

Adverse event: Blood sugar concerns
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 71 at risk

Adverse event: Breathing concerns
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 71 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 71 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 71 at risk

Adverse event: Donor source antibodies
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 71 at risk

Adverse event: Elevated Creatinine
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 21 affected / 71 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Immune system disorders
Frequency: 7 affected / 71 at risk

Adverse event: G Tube Concerns
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 71 at risk

Adverse event: Heart concerns
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 71 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 71 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 71 at risk

Adverse event: Mental Concerns
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 71 at risk

Adverse event: Severe Pain
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 71 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 71 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Immune system disorders
Frequency: 6 affected / 71 at risk

Adverse event: Urination Concerns
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 71 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 11 affected / 71 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 71 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 71 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 71 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 71 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 71 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 11 at risk

Adverse event: Alopecia
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 71 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 70 affected / 71 at risk

Adverse event: Liver function test abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 71 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 46 affected / 71 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 11 affected / 71 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 71 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 71 at risk