Study: NCT00129376

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 63 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 4 affected / 63 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Notes: Grade 3
Frequency: 1 affected / 63 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 63 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 2
Frequency: 1 affected / 63 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 63 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: Left Ventricular Ejection Fraction Grade 4
Frequency: 1 affected / 63 at risk

Adverse event: Cardiac-ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 63 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 3 affected / 63 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 5 affected / 63 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 4
Frequency: 26 affected / 63 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3
Frequency: 10 affected / 63 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 1 affected / 63 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Notes: Grade 3
Frequency: 1 affected / 63 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 1 affected / 63 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 3
Frequency: 1 affected / 63 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 4
Frequency: 2 affected / 63 at risk

Adverse event: Oedema
Serious: no
Organ System: Cardiac disorders
Notes: Grade 3
Frequency: 1 affected / 63 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Notes: Grade 3
Frequency: 5 affected / 63 at risk

Adverse event: Hepatic dysfunction
Serious: no
Organ System: Hepatobiliary disorders
Notes: Grade 3
Frequency: 2 affected / 63 at risk

Adverse event: Infection without neutropenia
Serious: no
Organ System: Infections and infestations
Notes: Grade 3
Frequency: 1 affected / 63 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 2 affected / 63 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Notes: Grade 3
Frequency: 1 affected / 63 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 3
Frequency: 5 affected / 63 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Notes: Grade 3
Frequency: 1 affected / 63 at risk