Study: NCT00378209

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 64 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 64 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: w/o prior colostomy
Frequency: 2 affected / 64 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 64 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 64 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 64 at risk

Adverse event: Pain: extremity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 64 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 64 at risk

Adverse event: Motor Neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 64 at risk

Adverse event: rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 64 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 64 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 64 at risk

Adverse event: Pulmonary/ Upper Respiratory Event
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 64 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 64 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 64 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: With concurrent grade 0-2 Neutropenia
Frequency: 1 affected / 64 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 64 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 64 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Without Neutropenia
Frequency: 1 affected / 64 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 64 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 34 affected / 64 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 29 affected / 64 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 64 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Without prior colostomy
Frequency: 24 affected / 64 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 25 affected / 64 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 64 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 64 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 64 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 64 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 18 affected / 64 at risk

Adverse event: Extremity Pain
Serious: no
Organ System: General disorders
Frequency: 14 affected / 64 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 64 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 64 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 64 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 64 at risk

Adverse event: Rash/ desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 64 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 8 affected / 64 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: without concurrent neutropenia
Frequency: 6 affected / 64 at risk

Adverse event: Motor Neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 64 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 64 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Endocrine disorders
Frequency: 8 affected / 64 at risk

Adverse event: Agitation
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 64 at risk

Adverse event: Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 64 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 7 affected / 64 at risk

Adverse event: neurologic- other
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 64 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 64 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 64 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 64 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 64 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 64 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 64 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 64 at risk

Adverse event: aspartate transaminase disorder
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 64 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 64 at risk

Adverse event: nonneuropatic generalized weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 64 at risk

Adverse event: Weight increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 64 at risk

Adverse event: alanine aminotransferase disorder
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 64 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 64 at risk

Adverse event: alkaline phosphatase disorder
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 64 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 64 at risk

Adverse event: cushingnoid appearance
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 64 at risk

Adverse event: ocular- other
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 64 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 64 at risk