Study: NCT00022633

Adverse event: Cardiovascular-other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Supraventricular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Flu-like symptoms-other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 51 at risk

Adverse event: Reportable adverse event, NOS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 51 at risk

Adverse event: Respiratory infect w/ neutrop
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 51 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 51 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 29 affected / 51 at risk

Adverse event: PRBC transfusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 51 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 51 at risk

Adverse event: Abdominal pain/cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 51 at risk

Adverse event: Constipation/bowel obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 51 at risk

Adverse event: Diarrhea without colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 51 at risk

Adverse event: Esophagitis/dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 51 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 51 at risk

Adverse event: Stomatitis/pharyngitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 51 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 51 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 14 affected / 51 at risk

Adverse event: Fatigue/malaise/lethargy
Serious: no
Organ System: General disorders
Frequency: 42 affected / 51 at risk

Adverse event: Fever without neutropenia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 51 at risk

Adverse event: Pain-other
Serious: no
Organ System: General disorders
Frequency: 8 affected / 51 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 6 affected / 51 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 4 affected / 51 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 51 at risk

Adverse event: Infection with 3-4 neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 51 at risk

Adverse event: Urinary tr infect w/o neutrop
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 51 at risk

Adverse event: Alkaline phosphatase increase
Serious: no
Organ System: Investigations
Frequency: 8 affected / 51 at risk

Adverse event: Creatinine increase
Serious: no
Organ System: Investigations
Frequency: 7 affected / 51 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 12 affected / 51 at risk

Adverse event: Neutropenia/granulocytopenia
Serious: no
Organ System: Investigations
Frequency: 36 affected / 51 at risk

Adverse event: SGOT (AST) increase
Serious: no
Organ System: Investigations
Frequency: 11 affected / 51 at risk

Adverse event: SGPT (ALT) increase
Serious: no
Organ System: Investigations
Frequency: 4 affected / 51 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 20 affected / 51 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 51 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 51 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 51 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 51 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 51 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 51 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 51 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 51 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 51 at risk

Adverse event: Dizziness/light headedness
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 51 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 51 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 51 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 51 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 51 at risk

Adverse event: Weakness (motor neuropathy)
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 51 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 51 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 51 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 51 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 51 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 51 at risk

Adverse event: Hiccoughs
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 51 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 51 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 51 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 51 at risk