Study: NCT00087672

Adverse event: Febrile neutropenia
Serious: yes
Organ System: General disorders
Notes: Unrelated to study drug.
Frequency: 1 affected / 41 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Unrelated to study drug.
Frequency: 1 affected / 41 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Unrelated to study drug.
Frequency: 1 affected / 41 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Notes: Unrelated to study drug.
Frequency: 2 affected / 41 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Unrelated to study drug.
Frequency: 1 affected / 41 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Unrelated to study drug
Frequency: 2 affected / 41 at risk

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Notes: Unrelated to study drug.
Frequency: 1 affected / 41 at risk

Adverse event: Infection with neutropenia
Serious: yes
Organ System: Infections and infestations
Notes: Unrelated to study drug.
Frequency: 2 affected / 41 at risk

Adverse event: Hemorrhage CNS
Serious: yes
Organ System: Vascular disorders
Notes: Unrelated to study drug.
Frequency: 1 affected / 41 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 41 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 41 at risk

Adverse event: Infection with unknown Absolute neutrophil count
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 41 at risk

Adverse event: Oedema
Serious: yes
Organ System: Cardiac disorders
Notes: Unrelated to study drug.
Frequency: 1 affected / 41 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Unrelated to study drug.
Frequency: 1 affected / 41 at risk

Adverse event: Obstruction Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Unrelated to study drug.
Frequency: 1 affected / 41 at risk

Adverse event: Syncope, sensory neuropathy
Serious: yes
Organ System: Nervous system disorders
Notes: Unrelated to study drug.
Frequency: 1 affected / 41 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 41 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 41 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 41 at risk

Adverse event: Metabolic/Laboratory (other)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 41 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 41 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 41 at risk

Adverse event: Neuropathy Sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 41 at risk

Adverse event: Neutrophils (ANC/AGC)
Serious: no
Organ System: Infections and infestations
Notes: ANC/AGC = Absolute Neutrophil Count/Absolute Granulocyte Count
Frequency: 14 affected / 41 at risk

Adverse event: pain (headache)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 41 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 41 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 41 at risk

Adverse event: Rash/Desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 41 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 41 at risk