Study: NCT00525915

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 63 at risk

Adverse event: NAUSEA/VOMITING
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 63 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 63 at risk

Adverse event: Gastrointestinal (GI) BLEED
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 63 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 63 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 63 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 63 at risk

Adverse event: DERMATITIS (RADIATION)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 63 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 54 affected / 63 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 63 at risk

Adverse event: Granulocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 63 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 51 affected / 63 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 63 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 63 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 48 affected / 63 at risk

Adverse event: NEUROPATHY SENSORY
Serious: no
Organ System: Nervous system disorders
Frequency: 37 affected / 63 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 63 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 63 at risk

Adverse event: Odynophagia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 63 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 5 affected / 63 at risk

Adverse event: INCREASE Alanine Aminotransferase (ALT)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 23 affected / 63 at risk

Adverse event: INCREASE Aspartate Aminotransferase (AST)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 21 affected / 63 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 63 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Investigations
Frequency: 12 affected / 63 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 3 affected / 63 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 63 at risk

Adverse event: Gastroesophageal reflux disease (GERD)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 63 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 63 at risk

Adverse event: RED, WATERY and BURNING EYES
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 63 at risk

Adverse event: Alopecia
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 63 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 63 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 41 affected / 63 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 63 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 63 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 63 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 63 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 63 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 63 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 63 at risk

Adverse event: Hiccups
Serious: no
Organ System: General disorders
Frequency: 20 affected / 63 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 63 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 8 affected / 63 at risk

Adverse event: TASTE CHANGE
Serious: no
Organ System: General disorders
Frequency: 25 affected / 63 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 63 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 63 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 63 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 63 at risk

Adverse event: Gastrointestinal (GI) BLEED
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 63 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 63 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 63 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 63 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 43 affected / 63 at risk

Adverse event: DERMATITIS (RADIATION)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 63 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 51 affected / 63 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 32 affected / 63 at risk

Adverse event: Granulocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 63 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 50 affected / 63 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 31 affected / 63 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 63 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 42 affected / 63 at risk

Adverse event: NEUROPATHY SENSORY
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 63 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 63 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 63 at risk

Adverse event: Odynophagia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 63 at risk

Adverse event: Dehydration
Serious: no
Organ System: General disorders
Frequency: 2 affected / 63 at risk

Adverse event: INCREASE Alanine Aminotransferase (ALT)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 19 affected / 63 at risk

Adverse event: INCREASE Aspartate Aminotransferase (AST)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 28 affected / 63 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 63 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Investigations
Frequency: 6 affected / 63 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 63 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 63 at risk

Adverse event: Gastroesophageal reflux disease (GERD)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 63 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 63 at risk

Adverse event: RED, WATERY and BURNING EYES
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 63 at risk

Adverse event: Alopecia
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 63 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 63 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 33 affected / 63 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 63 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 13 affected / 63 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 10 affected / 63 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 63 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 63 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 63 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 63 at risk

Adverse event: Hiccups
Serious: no
Organ System: General disorders
Frequency: 24 affected / 63 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 63 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 5 affected / 63 at risk

Adverse event: TASTE CHANGE
Serious: no
Organ System: General disorders
Frequency: 26 affected / 63 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 63 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 63 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 37 affected / 63 at risk