Study: NCT00075400

Adverse event: Death No Ctcae Term - Disease Progression Nos
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Death No Ctcae Term - Death Nos
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Obstruction, Gu - Ureter
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 23 at risk

Adverse event: Allergic Reaction/Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 23 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 23 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 23 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 23 at risk

Adverse event: S/N Arrhythmia: Atrial Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 17 affected / 23 at risk

Adverse event: Death No Ctcae Term - Disease Progression Nos
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hair Loss/Alopecia (Scalp Or Body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 23 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 23 at risk

Adverse event: Flushing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hot flush
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 23 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 23 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 23 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 23 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 23 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 23 at risk

Adverse event: Hemorrhage, Gu - Vagina
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 23 at risk

Adverse event: Hemorrhage, Gi - Rectum
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hemorrhage/Pulmonary - Respiratory Tract Nos
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 23 at risk

Adverse event: Liver Dysfunction
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 23 at risk

Adverse event: Inf W/Nml Or Gr 1 Or 2 Anc: Kidney
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Edema: Limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 23 at risk

Adverse event: Edema: Head And Neck
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 23 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 23 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 23 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 23 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 23 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 23 at risk

Adverse event: Blood bilirubin
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 23 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 23 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 23 at risk

Adverse event: Mood Alteration - Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 23 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 23 at risk

Adverse event: Neuropathy-Sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 23 at risk

Adverse event: Neuropathy-Motor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Watery Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 23 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 23 at risk

Adverse event: Pain: Chest /Thorax Nos
Serious: no
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Pain: Head/Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 23 at risk

Adverse event: Pain: Extremity-Limb
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Pain: Back
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Pain: Abdominal Pain Nos
Serious: no
Organ System: General disorders
Frequency: 3 affected / 23 at risk

Adverse event: Pain: Tumor
Serious: no
Organ System: General disorders
Frequency: 2 affected / 23 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 23 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 23 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 23 at risk

Adverse event: Incontinence, Urinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 23 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 23 at risk