Study: NCT00869050

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Hospitalized prior - reason unknown
Frequency: 1 affected / 38 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Notes: Hospitalized
Frequency: 1 affected / 38 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: General disorders
Notes: 1 participant - hospitalized due to vomiting and a stomach virus

1 participant - hospitalized due to seizures
Frequency: 2 affected / 38 at risk

Adverse event: Pain abdomen
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 38 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 38 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Night sweats
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 38 at risk

Adverse event: Confusional state
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Loss of apetite
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Arm and ankle pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hepatic pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 38 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 38 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Constipation
Serious: no
Organ System: General disorders
Frequency: 4 affected / 38 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Tingling lower lip
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Rash
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 38 at risk

Adverse event: Allergy to dye
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 4 affected / 38 at risk

Adverse event: Anxiety
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Depression
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Pancytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk