Study: NCT00787267

Adverse event: Decreased appetite
Serious: yes
Organ System: General disorders
Notes: NCI CTCAE version 3.0
Frequency: 1 affected / 25 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: NCI CTCAE version 3.0
Frequency: 1 affected / 25 at risk

Adverse event: decreased leukocytes
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: NCI CTCAE version 3.0
Frequency: 1 affected / 25 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Notes: NCI CTCAE version 3.0
Frequency: 1 affected / 25 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: NCI CTCAE version 3.0
Frequency: 6 affected / 25 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: NCI CTCAE version 3.0
Frequency: 5 affected / 25 at risk

Adverse event: hyponatremia - metabolic/lab
Serious: yes
Organ System: General disorders
Notes: NCI CTCAE version 3.0
Frequency: 1 affected / 25 at risk

Adverse event: muscle weakness (generalized)
Serious: yes
Organ System: General disorders
Notes: NCI CTCAE version 3.0
Frequency: 1 affected / 25 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: NCI CTCAE version 3.0
Frequency: 2 affected / 25 at risk

Adverse event: neuro-motor (generalized weakness)
Serious: yes
Organ System: General disorders
Notes: NCI CTCAE version 3.0
Frequency: 1 affected / 25 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: General disorders
Notes: NCI CTCAE version 3.0
Frequency: 1 affected / 25 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: NCI CTCAE version 3.0
Frequency: 1 affected / 25 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: NCI CTCAE version 3.0
Frequency: 6 affected / 25 at risk

Adverse event: bronchospasm (wheezing)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: NCI CTCAE version 3.0
Frequency: 2 affected / 25 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: NCI CTCAE version 3.0
Frequency: 8 affected / 25 at risk

Adverse event: decreased neutrophils
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: NCI CTCAE version 3.0
Frequency: 1 affected / 25 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: NCI CTCAE version 3.0
Frequency: 3 affected / 25 at risk

Adverse event: dizziness (lightheadedness)
Serious: no
Organ System: General disorders
Notes: NCI CTCAE version 3.0
Frequency: 1 affected / 25 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: NCI CTCAE version 3.0
Frequency: 2 affected / 25 at risk

Adverse event: edema (periorbital/face)
Serious: no
Organ System: General disorders
Notes: NCI CTCAE version 3.0
Frequency: 1 affected / 25 at risk

Adverse event: elevated AST
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: NCI CTCAE version 3.0
Frequency: 2 affected / 25 at risk

Adverse event: elevated creatinine
Serious: no
Organ System: Renal and urinary disorders
Notes: NCI CTCAE version 3.0
Frequency: 1 affected / 25 at risk

Adverse event: elevated LDH
Serious: no
Organ System: General disorders
Notes: NCI CTCAE version 3.0
Frequency: 1 affected / 25 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: NCI CTCAE version 3.0
Frequency: 8 affected / 25 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: NCI CTCAE version 3.0
Frequency: 1 affected / 25 at risk

Adverse event: hair loss (alopecia)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: NCI CTCAE version 3.0
Frequency: 1 affected / 25 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: NCI CTCAE version 3.0
Frequency: 1 affected / 25 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Notes: NCI CTCAE version 3.0
Frequency: 1 affected / 25 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: General disorders
Notes: NCI CTCAE version 3.0
Frequency: 1 affected / 25 at risk

Adverse event: muscle weakness - lower extremity (leg weakness)
Serious: no
Organ System: General disorders
Notes: NCI CTCAE version 3.0
Frequency: 1 affected / 25 at risk

Adverse event: muscle weakness (generalized)
Serious: no
Organ System: General disorders
Notes: NCI CTCAE version 3.0
Frequency: 1 affected / 25 at risk

Adverse event: myalgias (generalized)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: NCI CTCAE version 3.0
Frequency: 1 affected / 25 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: NCI CTCAE version 3.0
Frequency: 6 affected / 25 at risk

Adverse event: neutrophils (neutropenia)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: NCI CTCAE version 3.0
Frequency: 1 affected / 25 at risk

Adverse event: pain extremity (legs)
Serious: no
Organ System: General disorders
Notes: NCI CTCAE version 3.0
Frequency: 1 affected / 25 at risk

Adverse event: pain-joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: NCI CTCAE version 3.0
Frequency: 1 affected / 25 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: NCI CTCAE version 3.0
Frequency: 1 affected / 25 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: NCI CTCAE version 3.0
Frequency: 2 affected / 25 at risk

Adverse event: pleural effusion, bilateral
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: NCI CTCAE version 3.0
Frequency: 1 affected / 25 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Cardiac disorders
Notes: NCI CTCAE version 3.0
Frequency: 1 affected / 25 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: NCI CTCAE version 3.0
Frequency: 6 affected / 25 at risk

Adverse event: renal/genitourinary other (slow starting urinary stream)
Serious: no
Organ System: Renal and urinary disorders
Notes: NCI CTCAE version 3.0
Frequency: 1 affected / 25 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Notes: NCI CTCAE version 3.0
Frequency: 3 affected / 25 at risk

Adverse event: ulcers (scrotal)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: NCI CTCAE version 3.0
Frequency: 1 affected / 25 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: NCI CTCAE version 3.0
Frequency: 2 affected / 25 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Notes: NCI CTCAE version 3.0
Frequency: 2 affected / 25 at risk