Study: NCT00596947

Adverse event: Lymphocele
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Both events occurred post kidney transplant
Frequency: 2 affected / 9 at risk

Adverse event: Perinephric collection
Serious: yes
Organ System: Surgical and medical procedures
Notes: This subject also had a prior lymphocele
Frequency: 1 affected / 9 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: One patient had fever with perinephric fluid collection. Gram negative rods reported from fluid but not further identified. Other patient with fever was thought to have urinary tract infection, though no bug was identified.
Frequency: 2 affected / 9 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Endocrine disorders
Notes: Neither patient was noted to be diabetic pre-transplant.
Frequency: 1 affected / 9 at risk

Adverse event: Transplant rejection
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 9 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: 3 Vessel CABG
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 9 at risk

Adverse event: fungal infection of toes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: lower extremity edema
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 9 at risk

Adverse event: Hypertension
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 9 at risk

Adverse event: recurrence of gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: increased tacrolimus trough level
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 9 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 9 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: one patient also presented with concurrent vomiting
Frequency: 1 affected / 9 at risk

Adverse event: Anaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 9 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: increased hemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 9 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 9 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: headache every morning
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Vascular disorders
Notes: Gangrene of left toe, same patient had gangrene of right toe in past
Frequency: 1 affected / 9 at risk

Adverse event: lower extremity edema
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 9 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9 at risk

Adverse event: cytomegalovirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Post transplant lymphoproliferative disorder
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: was Epstein Barr positive, involved tongue and brain lesions, was ongoing at end of follow-up
Frequency: 1 affected / 9 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Endocrine disorders
Notes: Neither patient was noted to be diabetic pre-transplant.
Frequency: 1 affected / 9 at risk

Adverse event: Transplant rejection
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Wound drainage
Serious: no
Organ System: Surgical and medical procedures
Notes: no bug identified
Frequency: 1 affected / 9 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: bug identified as serratia marcescens
Frequency: 1 affected / 9 at risk

Adverse event: fungal infection of toes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: lower extremity edema
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 9 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 9 at risk

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Notes: same patient also had shortness of breath
Frequency: 1 affected / 9 at risk

Adverse event: Hypertension
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9 at risk

Adverse event: pain in right calf
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: patient lost to follow-up
Frequency: 1 affected / 9 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 9 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 9 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 9 at risk

Adverse event: recurrence of gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 9 at risk

Adverse event: increased tacrolimus trough level
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 9 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 9 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9 at risk

Adverse event: hand tremors related to tacrolimus therapy
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 9 at risk

Adverse event: Lymphocele
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: hospitalization was not required for any of these cases
Frequency: 2 affected / 9 at risk

Adverse event: reaccumulation of peritransplant fluid collection
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 9 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: one patient also presented with concurrent vomiting
Frequency: 2 affected / 9 at risk

Adverse event: seasonal allergies
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Anaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 9 at risk

Adverse event: Osteopenia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: One patient presented with concurrent osteoporosis of femoral region
Frequency: 2 affected / 9 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: patient presented with concurrent diarrhea
Frequency: 1 affected / 9 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: patient presented with concurrent osteopenia of lumbar area
Frequency: 1 affected / 9 at risk