Study: NCT00410826

Adverse event: Deafness
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 96 at risk

Adverse event: Cytopenias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 96 at risk

Adverse event: nausea,vomiting, dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 96 at risk

Adverse event: mucositis, esophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 96 at risk

Adverse event: peritonitis, perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 96 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 96 at risk

Adverse event: elevated creatinine
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 96 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 96 at risk

Adverse event: Pulmonary embolism, deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 96 at risk

Adverse event: mood alteration
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 96 at risk

Adverse event: Substance abuse, seizure
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 96 at risk

Adverse event: congestive heart disease, cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 96 at risk

Adverse event: Respiratory arrest, hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 96 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 96 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 96 at risk

Adverse event: Pharyngeal haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 96 at risk

Adverse event: dermatitis, rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 96 at risk

Adverse event: Pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 54 affected / 96 at risk

Adverse event: mucositis, nausea, vomiting, dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 96 at risk

Adverse event: Cytopenias
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 96 at risk

Adverse event: Cytopenias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 95 at risk

Adverse event: nausea,vomiting, dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 95 at risk

Adverse event: mucositis, esophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 95 at risk

Adverse event: peritonitis, perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 95 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 95 at risk

Adverse event: elevated creatinine
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 95 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 95 at risk

Adverse event: Pulmonary embolism, deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 95 at risk

Adverse event: mood alteration
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 95 at risk

Adverse event: Substance abuse, seizure
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 95 at risk

Adverse event: congestive heart disease, cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 95 at risk

Adverse event: Respiratory arrest, hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 95 at risk

Adverse event: dermatitis, rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 65 affected / 95 at risk

Adverse event: Pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 50 affected / 95 at risk

Adverse event: mucositis, nausea, vomiting, dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 95 at risk

Adverse event: Cytopenias
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 95 at risk