Study: NCT01377467

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 46 at risk

Adverse event: Transplant pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 46 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 46 at risk

Adverse event: Cytomegalovirus viraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Flu-like disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 46 at risk

Adverse event: Lymphocele
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 46 at risk

Adverse event: Acute rejection
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 46 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 46 at risk

Adverse event: Functional decline of transplant function
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 46 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 46 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 46 at risk

Adverse event: Neck/back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Generalized weakness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 46 at risk

Adverse event: Ureteral leakage
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 46 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 46 at risk

Adverse event: Aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 46 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 46 at risk

Adverse event: Infection without focus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 46 at risk

Adverse event: Hernia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Transplant reflux testing
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 46 at risk

Adverse event: Selective ureteral sampling
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 46 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Urethral stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 46 at risk

Adverse event: Urinary tract infections
Serious: no
Organ System: Infections and infestations
Notes: Cystitis (bladder infection)
Frequency: 12 affected / 46 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 46 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Endocrine disorders
Notes: Transient, asymptomatic hypocalcemia defined as total serum calcium \<1.9 mmol/L
Frequency: 12 affected / 46 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 46 at risk

Adverse event: Aphtous stomatitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 46 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 46 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 46 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 46 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 46 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 46 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 46 at risk

Adverse event: Neck/back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 46 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 46 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 46 at risk

Adverse event: Alopecia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 46 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 46 at risk

Adverse event: Fecal blood
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 46 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 5 affected / 46 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 46 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 46 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 46 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 44 at risk

Adverse event: Transplant pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 44 at risk

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

Adverse event: Cytomegalovirus viraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 44 at risk

Adverse event: Flu-like disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Lymphocele
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 44 at risk

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

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 44 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 44 at risk

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

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 44 at risk

Adverse event: Diabetes (post-transplant)
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 44 at risk

Adverse event: Surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 44 at risk

Adverse event: Functional decline of transplant function
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 44 at risk

Adverse event: Transplant ureter stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 44 at risk

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

Adverse event: Peripheral arterial vascular disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 44 at risk

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

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

Adverse event: Transplant artery stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 44 at risk

Adverse event: Uterus myomatosus
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 44 at risk

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

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

Adverse event: Bilateral nephrectomy of polycystic kidneys
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 44 at risk

Adverse event: Urinary tract infections
Serious: no
Organ System: Infections and infestations
Notes: Cystitis (bladder infection)
Frequency: 5 affected / 44 at risk

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

Adverse event: Hypocalcaemia
Serious: no
Organ System: Endocrine disorders
Notes: Transient, asymptomatic hypocalcemia defined as total serum calcium \<1.9 mmol/L
Frequency: 1 affected / 44 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 44 at risk

Adverse event: Aphtous stomatitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 44 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 44 at risk

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

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

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 44 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 44 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 44 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 44 at risk

Adverse event: Neck/back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 44 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: General disorders
Frequency: 3 affected / 44 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 44 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Alopecia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 44 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 44 at risk