Study: NCT00098020

Adverse event: Agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 8 at risk

Adverse event: Alopecia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 8 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Arthralgia (knee/ankle)
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Ascites
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 8 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 8 at risk

Adverse event: Conduction disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Creatinine Increased CTCAE
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 8 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dexamethasone x4 doses: start MMF and CSA
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dry skin (lips)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 8 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 8 at risk

Adverse event: Localised oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Facial pain
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Haemorrhoidal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dysphonia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 8 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 8 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Night blindness
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pacemaker placed
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Periorbital oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Upper-airway cough syndrome
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Productive cough
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 8 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Pain of skin
Serious: no
Organ System: General disorders
Frequency: 2 affected / 8 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 8 at risk

Adverse event: Presyncope
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 8 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk