Study: NCT00906204

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 44 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 44 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 44 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 44 at risk

Adverse event: BK virus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: C. difficile
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 44 at risk

Adverse event: Histoplasmosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: rATG reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 44 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 44 at risk

Adverse event: Renal tubular necrosis
Serious: yes
Organ System: Renal and urinary disorders
Notes: After post-transplantation day 7
Frequency: 2 affected / 44 at risk

Adverse event: Delayed graft function
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 44 at risk

Adverse event: Native nephrectomy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 44 at risk

Adverse event: Rejection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 44 at risk

Adverse event: Renal vein thrombosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Wound hernia repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 44 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 44 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 44 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 44 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 44 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 44 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 44 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 18 affected / 44 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 8 affected / 44 at risk

Adverse event: Hyperphosphataemia
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 44 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 44 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 15 affected / 44 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Endocrine disorders
Frequency: 6 affected / 44 at risk

Adverse event: Osteopenia
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 44 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 44 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 44 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 44 at risk

Adverse event: Gastric reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 44 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 44 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 44 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: General disorders
Frequency: 2 affected / 44 at risk

Adverse event: Tacrolimus elevation/toxicity
Serious: no
Organ System: General disorders
Frequency: 5 affected / 44 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 44 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 44 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Immune system disorders
Frequency: 12 affected / 44 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 44 at risk

Adverse event: BK virus
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 44 at risk

Adverse event: Pancytopenia
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 44 at risk

Adverse event: C. difficile
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 44 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Includes colds, sinusitis, bronchitis
Frequency: 5 affected / 44 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 44 at risk

Adverse event: Possible rATG reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 44 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 44 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 44 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 44 at risk

Adverse event: Elevated serum creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 44 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 44 at risk

Adverse event: Rejection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 44 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 44 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 44 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 44 at risk

Adverse event: Hernia
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 44 at risk

Adverse event: Wound complication
Serious: no
Organ System: Surgical and medical procedures
Notes: Includes wound hematoma, seroma, drainage, slow healing
Frequency: 4 affected / 44 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 51 at risk

Adverse event: Serum sickness
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 51 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Atypical chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 51 at risk

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 51 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: Exposure to communicable disease
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 51 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 51 at risk

Adverse event: C. difficile
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Viral Gasteroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 51 at risk

Adverse event: Chronic lymphocytic leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 51 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 51 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 51 at risk

Adverse event: Renal tubular necrosis
Serious: yes
Organ System: Renal and urinary disorders
Notes: After post-transplantation day 7
Frequency: 1 affected / 51 at risk

Adverse event: Delayed graft function
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 51 at risk

Adverse event: Interstitial nephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 51 at risk

Adverse event: Nephrostomy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 51 at risk

Adverse event: Perinephric hematoma
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 51 at risk

Adverse event: Rejection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 51 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 51 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 51 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 51 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 51 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 51 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 51 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 51 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 21 affected / 51 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 12 affected / 51 at risk

Adverse event: Hyperparathyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 51 at risk

Adverse event: Hyperphosphataemia
Serious: no
Organ System: Endocrine disorders
Frequency: 7 affected / 51 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 7 affected / 51 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 12 affected / 51 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Endocrine disorders
Frequency: 6 affected / 51 at risk

Adverse event: Osteopenia
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 51 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 51 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 51 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 51 at risk

Adverse event: Gastric reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 51 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 51 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 9 affected / 51 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: General disorders
Frequency: 4 affected / 51 at risk

Adverse event: Tacrolimus elevation/toxicity
Serious: no
Organ System: General disorders
Frequency: 2 affected / 51 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 51 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Immune system disorders
Frequency: 10 affected / 51 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Immune system disorders
Frequency: 18 affected / 51 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 51 at risk

Adverse event: BK virus
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 51 at risk

Adverse event: Pancytopenia
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 51 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Includes colds, sinusitis, bronchitis
Frequency: 6 affected / 51 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 51 at risk

Adverse event: Possible rATG reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 51 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 51 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 51 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 51 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 51 at risk

Adverse event: Elevated serum creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 51 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 51 at risk

Adverse event: Rejection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 51 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 51 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 51 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 51 at risk

Adverse event: Hernia
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 51 at risk

Adverse event: Wound complication
Serious: no
Organ System: Surgical and medical procedures
Notes: Includes wound hematoma, seroma, drainage, slow healing
Frequency: 3 affected / 51 at risk