Study: NCT00310076

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 27 at risk

Adverse event: Cardiovascular/General-other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 27 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Dysphagia, esophagitis, odynophagia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: other gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hypertension
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 27 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Hypotension
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Infection with unknown ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 27 at risk

Adverse event: Infection/Febrile Neutropenia-Other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 27 at risk

Adverse event: Neuro-mood
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 27 at risk

Adverse event: Neuro-motor
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 27 at risk

Adverse event: Neurosensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 27 at risk

Adverse event: Pain-other
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 27 at risk

Adverse event: Thrombosis/Embolism
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 27 at risk

Adverse event: Ureteral Obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 27 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 27 at risk

Adverse event: Weight increased
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Investigations
Frequency: 10 affected / 27 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 3 affected / 27 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 8 affected / 27 at risk

Adverse event: Alopecia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 27 at risk

Adverse event: Oedema
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 27 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Investigations
Frequency: 3 affected / 27 at risk

Adverse event: Dizziness/vertigo
Serious: no
Organ System: General disorders
Frequency: 4 affected / 27 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Neurologic Other
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 27 at risk

Adverse event: Dermatological
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 27 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 4 affected / 27 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 14 affected / 27 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 27 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 8 affected / 27 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 27 at risk

Adverse event: Coagulation Other
Serious: no
Organ System: Investigations
Frequency: 2 affected / 27 at risk

Adverse event: Hot flashes/flushes
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Endocrine Other
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 27 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 27 at risk

Adverse event: Serum glutamic pyruvic transaminase
Serious: no
Organ System: Investigations
Frequency: 7 affected / 27 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 5 affected / 27 at risk

Adverse event: Serum glutamic oxaloacetic transaminase
Serious: no
Organ System: Investigations
Frequency: 5 affected / 27 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 27 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 27 at risk

Adverse event: Fever in the absence of neutropenia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 27 at risk

Adverse event: Infection-Other
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 27 at risk

Adverse event: Auditory/Ear-Other
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 27 at risk