Study: NCT00815685

Adverse event: CNS
Serious: yes
Organ System: Vascular disorders
Notes: Grade 3 - unrelated
Frequency: 1 affected / 36 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3 - unrelated
Frequency: 2 affected / 36 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3 - unrelated
Frequency: 2 affected / 36 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3 - unrelated
Frequency: 1 affected / 36 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: General disorders
Notes: Grade 3 - unrelated
Frequency: 2 affected / 36 at risk

Adverse event: Glucose serum-high
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3 - unrelated
Frequency: 1 affected / 36 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 3 - unrelated
Frequency: 1 affected / 36 at risk

Adverse event: Mucositis/stomach - Oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3 - unrelated
Frequency: 1 affected / 36 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3 - unrelated
Frequency: 2 affected / 36 at risk

Adverse event: Pain - Chest/Thorax
Serious: yes
Organ System: General disorders
Notes: Grade 3 - unrelated
Frequency: 1 affected / 36 at risk

Adverse event: Pain - abdomen
Serious: yes
Organ System: General disorders
Notes: Grade 3 - unrelated
Frequency: 1 affected / 36 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3 - unrelated
Frequency: 1 affected / 36 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 3 - unrelated
Frequency: 1 affected / 36 at risk

Adverse event: Potassium serum-low
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 3 - unrelated
Frequency: 2 affected / 36 at risk

Adverse event: Vomitting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Grade 3 - unrelated
Frequency: 2 affected / 36 at risk

Adverse event: Albumin, serum-low (hypoalbuminemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1-3 - unrelated
Frequency: 2 affected / 36 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1 - unlikely to be related
Frequency: 2 affected / 36 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1-3 - unlikely to be related
Frequency: 5 affected / 36 at risk

Adverse event: Bruising in absence of Grade 3 or 4 thrombocytopenia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1 - unlikely to be related
Frequency: 1 affected / 36 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1-3 - possibly related
Frequency: 2 affected / 36 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2 - unlikely to be related
Frequency: 1 affected / 36 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2 - possibly related
Frequency: 1 affected / 36 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 - unlikely to be related
Frequency: 2 affected / 36 at risk

Adverse event: Distension/bloating, abdominal
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 - unlikely to be related
Frequency: 1 affected / 36 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: Grade 1-3 - unlikely to be related
Frequency: 2 affected / 36 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1-3 - unlikely to be related
Frequency: 3 affected / 36 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2 - unrelated
Frequency: 1 affected / 36 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1-3 - unlikely to be related
Frequency: 11 affected / 36 at risk

Adverse event: Glucose, serum-high
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1-3 - unrelated
Frequency: 1 affected / 36 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1-3 - unlikely to be related
Frequency: 5 affected / 36 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1-3 - unlikely to be related
Frequency: 3 affected / 36 at risk

Adverse event: Hemorrhage: nose
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1-3 - unlikely to be related
Frequency: 2 affected / 36 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: Grade 1-3 - unlikely to be related
Frequency: 1 affected / 36 at risk

Adverse event: International Normalized Ratio of prothrombin time (INR)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1-3 - unrelated
Frequency: 1 affected / 36 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 2 - unlikely to be related
Frequency: 1 affected / 36 at risk

Adverse event: Mucositis/stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 - unlikely to be related
Frequency: 2 affected / 36 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1-3 - unrelated
Frequency: 2 affected / 36 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1-3 - unlikely to be related
Frequency: 1 affected / 36 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1-3 - unlikely to be related
Frequency: 3 affected / 36 at risk

Adverse event: Nasal cavity/paranasal sinus reaction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1-3 - unlikely to be related
Frequency: 1 affected / 36 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1 - possibly related
Frequency: 1 affected / 36 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1-3 - unrelated
Frequency: 1 affected / 36 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1-3 - unlikely to be related
Frequency: 8 affected / 36 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Grade 1 - unlikely to be related
Frequency: 1 affected / 36 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 3 - unrelated
Frequency: 1 affected / 36 at risk

Adverse event: Opthalmoplegia/diplopia (double vision)
Serious: no
Organ System: Eye disorders
Notes: Grade 1-3 - unlikely to be related
Frequency: 1 affected / 36 at risk

Adverse event: Pain - Chest/thorax NOS
Serious: no
Organ System: General disorders
Notes: Grade 1-3 - unlikely to be related
Frequency: 2 affected / 36 at risk

Adverse event: Pain - Extremity-limb
Serious: no
Organ System: General disorders
Notes: Grade 1 - unlikely to be related
Frequency: 1 affected / 36 at risk

Adverse event: Pain - back
Serious: no
Organ System: General disorders
Notes: Grade 1 - unlikely to be related
Frequency: 1 affected / 36 at risk

Adverse event: Pain - head/headache
Serious: no
Organ System: General disorders
Notes: Grade 2 - unlikely to be related
Frequency: 1 affected / 36 at risk

Adverse event: Pain - lymph node
Serious: no
Organ System: General disorders
Notes: Grade 1 - unrelated
Frequency: 1 affected / 36 at risk

Adverse event: Pain - neck
Serious: no
Organ System: General disorders
Notes: Grade 1 - unlikely to be related
Frequency: 1 affected / 36 at risk

Adverse event: Pain - sinus
Serious: no
Organ System: General disorders
Notes: Grade 1-3 - unlikely to be related
Frequency: 1 affected / 36 at risk

Adverse event: Pain - stomach
Serious: no
Organ System: General disorders
Notes: Grade 1-3 - unlikely to be related
Frequency: 1 affected / 36 at risk

Adverse event: Partial Thromboplastin Time (PTT)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1-3 - unrelated
Frequency: 1 affected / 36 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Grade 1 - unrelated
Frequency: 1 affected / 36 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Notes: Grade 2 - unrelated
Frequency: 1 affected / 36 at risk

Adverse event: Sodium, serum-low
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 1-3 - unrelated
Frequency: 1 affected / 36 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Notes: Grade 1 - unlikely to be related
Frequency: 1 affected / 36 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1-3 - unlikely to be related
Frequency: 2 affected / 36 at risk

Adverse event: Urine color change
Serious: no
Organ System: Renal and urinary disorders
Notes: Grade 1 - unlikely to be related
Frequency: 1 affected / 36 at risk

Adverse event: Voice changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1-3 - unlikely to be related
Frequency: 1 affected / 36 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1-3 - unlikely to be related
Frequency: 4 affected / 36 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Notes: Grade 2 - unrelated
Frequency: 1 affected / 36 at risk