Study: NCT00361296

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 5 at risk

Adverse event: ALT elevated
Serious: no
Organ System: Investigations
Frequency: 2 affected / 5 at risk

Adverse event: Altered mental status
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Anaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 5 at risk

Adverse event: AST elevated
Serious: no
Organ System: Investigations
Frequency: 2 affected / 5 at risk

Adverse event: Bacteraemia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Bleeding - eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 5 at risk

Adverse event: Contusion
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 5 at risk

Adverse event: Creatinine elevated
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 5 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Oedema
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 5 at risk

Adverse event: Erythema - mouth
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Flushing
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 5 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Hyperphosphataemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Injection site reactions
Serious: no
Organ System: Immune system disorders
Frequency: 5 affected / 5 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 5 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Lyme disease
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 5 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 5 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Epistaxis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Pain - flank
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Night sweats
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 5 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 5 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Swollen gums
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Taste changes
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 5 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Transfusion reaction
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Vision changes
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Xerophthalmia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 5 at risk

Adverse event: Xerosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Zoster infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk