Study: NCT00716456

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Dermatitis acneiform
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3 at risk

Adverse event: Mucositis-Oral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Rash acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 3 at risk

Adverse event: Allergic reaction/Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 5 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 5 at risk

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

Adverse event: Dry skin
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: 3 affected / 5 at risk

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

Adverse event: Hemorrhage, Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Inf unknown ANC-Ungual (Nails)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 5 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 5 at risk

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

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

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 5 at risk

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

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Aspartate aminotransferase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Gait disturbance
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 13 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 13 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 13 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 13 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 13 at risk

Adverse event: Hemorrhage, Nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 13 at risk

Adverse event: Mucositis-Oral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 13 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 13 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 13 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 13 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 13 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 13 at risk