Study: NCT00227721

Adverse event: Absolute neutrophil count (ANC)
Serious: yes
Organ System: Investigations
Frequency: 14 affected / 29 at risk

Adverse event: White Blood Count (WBC)
Serious: yes
Organ System: Investigations
Frequency: 10 affected / 29 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 29 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 29 at risk

Adverse event: Hemoglobin (HGB)
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 29 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 29 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 29 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: Infection w/o Neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 29 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Elevated Aspartate aminotransferase (AST)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: Elevated total bilirubin
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 29 at risk

Adverse event: Abnormal magnesium
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Fluid Retention Syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 29 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 29 at risk

Adverse event: Abnormal electrolytes
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 29 at risk

Adverse event: Absolute neutrophil count (ANC)
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 29 at risk

Adverse event: White blood cell count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 29 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 29 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 21 affected / 29 at risk

Adverse event: Hemoglobin (HGB)
Serious: no
Organ System: Investigations
Frequency: 24 affected / 29 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 16 affected / 29 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 29 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 29 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 29 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 29 at risk

Adverse event: Elevated aspartate aminotransferase (AST)
Serious: no
Organ System: Investigations
Frequency: 6 affected / 29 at risk

Adverse event: Elevated total bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 29 at risk

Adverse event: Abnormal magnesium
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 29 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 29 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 29 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 29 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 29 at risk

Adverse event: Elevated Alanine Aminotransferase (ALT)
Serious: no
Organ System: Investigations
Frequency: 7 affected / 29 at risk

Adverse event: Elevated creatinine/bun
Serious: no
Organ System: Investigations
Frequency: 5 affected / 29 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 29 at risk

Adverse event: Blood albumin
Serious: no
Organ System: Investigations
Frequency: 2 affected / 29 at risk

Adverse event: Blood glucose
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 29 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 29 at risk