Study: NCT00673738

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Low Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 27 at risk

Adverse event: Supraventricular and nodal arrhythmia - Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 27 at risk

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

Adverse event: Sweating (diaphoresis)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Death not associated with CTCAE term - Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Death not associated with CTCAE term - Sudden death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 27 at risk

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

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

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

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

Adverse event: Dysphagia (difficulty swallowing)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 27 at risk

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

Adverse event: Mucositis/stomatitis (functional/symptomatic) - Oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

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

Adverse event: Stricture/stenosis (including anastomotic), GI - Esophagus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

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

Adverse event: Hemorrhage, pulmonary/upper respiratory - Respiratory tract NOS
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 27 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lung
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Urinary Tract
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Esophagus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 27 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

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

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk

Adverse event: Potassium, serum-low (hypokalemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 27 at risk

Adverse event: Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Musculoskeletal/Soft Tissue - Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Mood alteration - Agitation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Pain - Abdomen NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Pain - Throat/pharynx/larynx
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 27 at risk

Adverse event: Hiccoughs (hiccups, singultus)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 27 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 27 at risk

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

Adverse event: Urinary retention (including neurogenic bladder)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 27 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 27 at risk

Adverse event: Dysphagia (difficulty swallowing)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 27 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 27 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 27 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 27 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 27 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 27 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 27 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 27 at risk

Adverse event: Stricture/stenosis (including anastomotic), GI - Esophagus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 27 at risk

Adverse event: Taste alteration (dysgeusia)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 27 at risk

Adverse event: Heartburn/dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Mucositis/stomatitis clinical exam) - Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Fatigue (asthenia, lethargy, malaise)
Serious: no
Organ System: General disorders
Frequency: 22 affected / 27 at risk

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

Adverse event: Constitutional Symptoms - Other
Serious: no
Organ System: General disorders
Frequency: 4 affected / 27 at risk

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

Adverse event: Fever (in the absence of neutropenia)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 27 at risk

Adverse event: Sweating (diaphoresis)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Rash: dermatitis associated with radiation - Radiation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 27 at risk

Adverse event: Pruritus/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 27 at risk

Adverse event: Rash: acne/acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 27 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 27 at risk

Adverse event: Hair loss/alopecia (scalp or body)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 27 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 27 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 27 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 27 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 27 at risk

Adverse event: Hiccoughs
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Pulmonary/Upper Respiratory - Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Pain - Head/headache
Serious: no
Organ System: General disorders
Frequency: 6 affected / 27 at risk

Adverse event: Pain - Back
Serious: no
Organ System: General disorders
Frequency: 4 affected / 27 at risk

Adverse event: Pain - Chest/thorax NOS
Serious: no
Organ System: General disorders
Frequency: 4 affected / 27 at risk

Adverse event: Pain - Throat/pharynx/larynx
Serious: no
Organ System: General disorders
Frequency: 4 affected / 27 at risk

Adverse event: Pain - Abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 3 affected / 27 at risk

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

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

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 27 at risk

Adverse event: Febrile neutropenia (fever of unknown origin)
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 27 at risk

Adverse event: Infection with normal ANC or Grade 1 or 2 neutrophils - Bronchus
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 27 at risk

Adverse event: Infection with unknown ANC - Oral cavity-gums (gingivitis)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 27 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 6 affected / 27 at risk

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

Adverse event: Musculoskeletal/Soft Tissue - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 27 at risk

Adverse event: Muscle weakness generalized or specific area (not due to neuropathy) whole body/generalized
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 27 at risk

Adverse event: Magnesium, serum-low (hypomagnesemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 27 at risk

Adverse event: Potassium, serum-high (hyperkalemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 27 at risk

Adverse event: Sodium, serum-low (hyponatremia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 27 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 27 at risk

Adverse event: Edema: head and neck
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 27 at risk

Adverse event: Allergic reaction/hypersensitivity (including drug fever)
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 27 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 27 at risk

Adverse event: Ocular/Visual - Other
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 27 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 27 at risk

Adverse event: Low Neutrophils/granulocytes (ANC/AGC)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 27 at risk