Study: NCT00463840

Adverse event: Leukocytes (Total Wbc)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Ascites (Non-Malignant)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 24 at risk

Adverse event: Diarrhea Patients Without Colostomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Gastrointestinal-Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Infection With Unknown Anc
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 24 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 24 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 24 at risk

Adverse event: Dizziness/Lightheadedness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Neuropathy - Motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Abdominal Pain Or Cramping
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Pulmonary-Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 24 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 24 at risk

Adverse event: Leukocytes (Total Wbc)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 24 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 21 affected / 24 at risk

Adverse event: Neutrophils/Granulocytes (Anc/Agc)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 24 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 24 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 24 at risk

Adverse event: Oedema
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 24 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 24 at risk

Adverse event: Fatigue (Lethargy, Malaise, Asthenia)
Serious: no
Organ System: General disorders
Frequency: 21 affected / 24 at risk

Adverse event: Fever (In The Absence Of Neutropenia, Where Neutropenia Is Defined As Agc<1.0 X 10e9/L)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 24 at risk

Adverse event: Rigors, Chills
Serious: no
Organ System: General disorders
Frequency: 3 affected / 24 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 7 affected / 24 at risk

Adverse event: Dermatology/Skin-Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 24 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 24 at risk

Adverse event: Rash/Desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 24 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 24 at risk

Adverse event: Ascites (Non-Malignant)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 24 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Diarrhea Patients Without Colostomy
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 24 at risk

Adverse event: Dyspepsia/Heartburn
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 24 at risk

Adverse event: Gastrointestinal-Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 24 at risk

Adverse event: Mucositis Due To Radiation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 24 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 24 at risk

Adverse event: Stomatitis/Pharyngitis (Oral/Pharyngeal Mucositis)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 24 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 24 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 10 affected / 24 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 24 at risk

Adverse event: Serum Glutamic Oxaloacetic Transaminase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 24 at risk

Adverse event: Serum Glutamic Pyruvic Transaminase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 24 at risk

Adverse event: Infection Without Neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 24 at risk

Adverse event: Blood bicarbonate
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 24 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 24 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 24 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 24 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 24 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 24 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 24 at risk

Adverse event: Dizziness/Lightheadedness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 24 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 24 at risk

Adverse event: Neuropathy - Motor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 24 at risk

Adverse event: Neuropathy-Sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 24 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 24 at risk

Adverse event: Abdominal Pain Or Cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Chest Pain (Non-Cardiac And Non-Pleuritic)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Pain-Other
Serious: no
Organ System: General disorders
Frequency: 6 affected / 24 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 24 at risk

Adverse event: Hiccoughs (Hiccups, Singultus)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 24 at risk