Study: NCT01936519

Adverse event: Leukopenia
Serious: no
Organ System: Immune system disorders
Notes: Low white cell count
Frequency: 7 affected / 12 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hyperlipidemia requiring treatment
Frequency: 7 affected / 12 at risk

Adverse event: Cellular Rejection
Serious: no
Organ System: Immune system disorders
Notes: T-cell mediated liver organ rejection
Frequency: 1 affected / 12 at risk

Adverse event: antibody mediated rejection
Serious: no
Organ System: Immune system disorders
Notes: Donor specific antibody positive level.
Frequency: 1 affected / 12 at risk

Adverse event: Cytomegalovirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 12 at risk

Adverse event: Minor Infection
Serious: no
Organ System: Infections and infestations
Notes: Minor infections includes: ascites infection, upper respiratory infection, sinusitis, fever, cholangitis, cold/flu.
Frequency: 3 affected / 12 at risk

Adverse event: Clostridium Difficile
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Herpes Simplex & Zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Frequency: 4 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Depression
Serious: no
Organ System: Nervous system disorders
Notes: Depression requiring treatment \&/or psychiatric evaluation
Frequency: 1 affected / 12 at risk

Adverse event: Temor
Serious: no
Organ System: Nervous system disorders
Notes: Tremor of the upper extremities
Frequency: 1 affected / 12 at risk

Adverse event: Mental status changes
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Anaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 12 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Low serum magnesium requiring correction
Frequency: 5 affected / 12 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Low serum calcium level
Frequency: 1 affected / 12 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Low serum potassium level
Frequency: 1 affected / 12 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: High serum glucose level
Frequency: 2 affected / 12 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: High serum potassium level requiring correction/treatment
Frequency: 3 affected / 12 at risk

Adverse event: Fluid retention
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Edema of the lower extremities and increased weight due to fluid retention
Frequency: 1 affected / 12 at risk

Adverse event: Skin cancer
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Squamous and/or basal cell skin cancer
Frequency: 2 affected / 12 at risk

Adverse event: Hepatic steatosis
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Fatty liver
Frequency: 1 affected / 12 at risk

Adverse event: Low Serum Testosterone Level
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Serum Testosterone level was measured at baseline, 6, 12 \& 24 months. Was significantly lower at 6 \& 12 months in the Everolimus arm and showed a lower trend at 24 months.
Frequency: 3 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 12 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: Upper Gastrointestinal bleed
Serious: no
Organ System: Gastrointestinal disorders
Notes: Upper gastrointestinal bleeding from duodenal arterio-venous malformation
Frequency: 1 affected / 12 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 12 at risk

Adverse event: Hepatic artery thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: Subject was found to have incidentally a hepatic artery thrombosis at 6 months on a CT scan for tumor screening. Liver function tests were normal and patient was asymptomatic.
Frequency: 1 affected / 12 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Immune system disorders
Notes: Low white cell count
Frequency: 9 affected / 12 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hyperlipidemia requiring treatment
Frequency: 9 affected / 12 at risk

Adverse event: Cellular Rejection
Serious: no
Organ System: Immune system disorders
Notes: T-cell mediated liver organ rejection
Frequency: 3 affected / 12 at risk

Adverse event: antibody mediated rejection
Serious: no
Organ System: Immune system disorders
Notes: Donor specific antibody positive level.
Frequency: 2 affected / 12 at risk

Adverse event: Cytomegalovirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 12 at risk

Adverse event: Hepatitis C
Serious: no
Organ System: Infections and infestations
Notes: Hepatitis c infection recurrence after liver transplantation
Frequency: 1 affected / 12 at risk

Adverse event: Minor Infection
Serious: no
Organ System: Infections and infestations
Notes: Minor infections includes: ascites infection, upper respiratory infection, sinusitis, fever, cholangitis, cold/flu.
Frequency: 5 affected / 12 at risk

Adverse event: Dental Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Herpes Simplex & Zoster
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 12 at risk

Adverse event: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 12 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Frequency: 3 affected / 12 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pulmonary hypertension of unknown cause. Treated.
Frequency: 1 affected / 12 at risk

Adverse event: Depression
Serious: no
Organ System: Nervous system disorders
Notes: Depression requiring treatment \&/or psychiatric evaluation
Frequency: 1 affected / 12 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Anaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 12 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Low serum magnesium requiring correction
Frequency: 1 affected / 12 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Low serum calcium level
Frequency: 1 affected / 12 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Low serum potassium level
Frequency: 1 affected / 12 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: High serum potassium level requiring correction/treatment
Frequency: 2 affected / 12 at risk

Adverse event: Fluid retention
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Edema of the lower extremities and increased weight due to fluid retention
Frequency: 2 affected / 12 at risk

Adverse event: Low Serum Testosterone Level
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Serum Testosterone level was measured at baseline, 6, 12 \& 24 months. Was significantly lower at 6 \& 12 months in the Everolimus arm and showed a lower trend at 24 months.
Frequency: 5 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk