Study: NCT00112463

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 38 at risk

Adverse event: Cardiac Arrhythmia - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 38 at risk

Adverse event: Cardiac Dysrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: Cardiac General - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 38 at risk

Adverse event: Coagulation - Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 38 at risk

Adverse event: GI - Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 38 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Malise/Fatigue
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 38 at risk

Adverse event: Metabolic - Other
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 38 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 38 at risk

Adverse event: Pain - Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 38 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 38 at risk

Adverse event: AGC/ANC
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 38 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 38 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 38 at risk

Adverse event: Caridac General - Other
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 38 at risk

Adverse event: Coagulation - Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 38 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 38 at risk

Adverse event: Constitutional Symptioms - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 38 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 38 at risk

Adverse event: Dermatology/Skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 38 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 38 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 38 at risk

Adverse event: Dyspepsia/Heartburn
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 38 at risk

Adverse event: Dyspnea/SOB
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 38 at risk

Adverse event: Fever in the absence of neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 38 at risk

Adverse event: GI - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 38 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 38 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 38 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 38 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 38 at risk

Adverse event: Malise/Fatigue
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 32 affected / 38 at risk

Adverse event: Metabolic - Other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 38 at risk

Adverse event: Mucositis/stomatitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 38 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 38 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 38 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 38 at risk

Adverse event: Neurologic - Other
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 38 at risk

Adverse event: Pain - Other
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 38 at risk

Adverse event: Pain: Abdomen NOS
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 38 at risk

Adverse event: Pain: Back
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 38 at risk

Adverse event: Pain: Extremity-limb
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 38 at risk

Adverse event: Pain: Head/Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 38 at risk

Adverse event: Pain: NOS
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 38 at risk

Adverse event: Pulmonary Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 38 at risk

Adverse event: Renal/Genitourinary - Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 38 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 38 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 38 at risk

Adverse event: White blood cell count
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 38 at risk

Adverse event: Weight increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 38 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 38 at risk