Study: NCT00516165

Adverse event: Grade 5-Death within 30 days.
Serious: yes
Organ System: General disorders
Notes: Unrelated
Frequency: 4 affected / 28 at risk

Adverse event: Grade 3 Encephalopathy-unrelated
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Grade 4 Anemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Unlikely related
Frequency: 1 affected / 28 at risk

Adverse event: Grade 4 Thrombocytopenia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: unrelated
Frequency: 1 affected / 28 at risk

Adverse event: Grade 4-Hypoxia
Serious: yes
Organ System: General disorders
Notes: possibly related
Frequency: 1 affected / 28 at risk

Adverse event: Grade 4 Bilirubin
Serious: yes
Organ System: Gastrointestinal disorders
Notes: unrelated
Frequency: 1 affected / 28 at risk

Adverse event: Grade 4 Hypophosphatemis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: unrelated
Frequency: 1 affected / 28 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: General disorders
Notes: unrelated
Frequency: 1 affected / 28 at risk

Adverse event: Grade 4 elevated SGOT
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Unrelated
Frequency: 1 affected / 28 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 13 affected / 28 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 28 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 28 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 28 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 10 affected / 28 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 10 affected / 28 at risk

Adverse event: Aspartate transaminase
Serious: no
Organ System: Investigations
Frequency: 9 affected / 28 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 28 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 28 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 28 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 28 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 28 at risk

Adverse event: Alanine transaminase
Serious: no
Organ System: Investigations
Frequency: 6 affected / 28 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 28 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 4 affected / 28 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Investigations
Frequency: 4 affected / 28 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 28 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 28 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 28 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 28 at risk

Adverse event: Acne rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 28 at risk

Adverse event: Oedema
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 28 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 28 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 28 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 28 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 28 at risk

Adverse event: Fever without neuropenia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 28 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Investigations
Frequency: 2 affected / 28 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 2 affected / 28 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 28 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 28 at risk

Adverse event: Pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 28 at risk