Study: NCT00153803

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Supraventricular and nodal arrhythmia
Frequency: 2 affected / 118 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 118 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 118 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 118 at risk

Adverse event: Gastrointestinal - Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Constitutional Symptoms - Fatigue
Serious: yes
Organ System: General disorders
Notes: Fatigue (asthenia, lethargy, malaise)
Frequency: 1 affected / 118 at risk

Adverse event: Constitutional Symptoms- Other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 118 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory- Lung
Serious: yes
Organ System: General disorders
Notes: Hemorrhage, pulmonary/upper respiratory- Lung
Frequency: 1 affected / 118 at risk

Adverse event: Hemorrhage/Bleeding - Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 118 at risk

Adverse event: Pain - Joint
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 118 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Notes: Allergic reaction/hypersensitivity (including drug fever)
Frequency: 1 affected / 118 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Notes: Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection)(ANC \<1.0 x 10e9/L, fever \>=38.5 degrees C)
Frequency: 1 affected / 118 at risk

Adverse event: Infection - Blood
Serious: yes
Organ System: Infections and infestations
Notes: Infection with normal ANC or Grade 1 or 2 neutrophils Blood
Frequency: 1 affected / 118 at risk

Adverse event: Infection - Foreign body
Serious: yes
Organ System: Infections and infestations
Notes: Infection with normal ANC or Grade 1 or 2 neutrophils Foreign body (e.g., graft, implant, prosthesis, stent)
Frequency: 1 affected / 118 at risk

Adverse event: Infection - Lung
Serious: yes
Organ System: Infections and infestations
Notes: Infection with normal ANC or Grade 1 or 2 neutrophils Lung (pneumonia)
Frequency: 1 affected / 118 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 118 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 118 at risk

Adverse event: Somnolence/depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 118 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Upper Respiratory - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 118 at risk

Adverse event: Skin - Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 118 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 118 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 118 at risk

Adverse event: Vascular - Other
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 118 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Allergic reaction/hypersensitivity (including drug fever)
Frequency: 1 affected / 118 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 118 at risk

Adverse event: Cardiac General - Other
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 118 at risk

Adverse event: Constitutional symptoms - Fever
Serious: no
Organ System: General disorders
Notes: Fever (in the absence of neutropenia, where neutropenia is defined as ANC \<1.0 x 10e9/L)
Frequency: 1 affected / 118 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Gastrointestinal - Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Pain - Chest/Thorax
Serious: no
Organ System: General disorders
Frequency: 2 affected / 118 at risk

Adverse event: Pain - Other
Serious: no
Organ System: General disorders
Frequency: 1 affected / 118 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Supraventricular and nodal arrhythmia
Frequency: 1 affected / 117 at risk

Adverse event: Cardiac General
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac General
Frequency: 1 affected / 117 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac ischemia/infarction
Frequency: 1 affected / 117 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 117 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Ventricular arrhythmia
Frequency: 1 affected / 117 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 117 at risk

Adverse event: Dysphagia (difficulty swallowing)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 117 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 117 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Gastritis (including bile reflux gastritis)
Frequency: 1 affected / 117 at risk

Adverse event: Mucositis/stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Mucositis/stomatitis (functional/symptomatic) Esophagus
Frequency: 2 affected / 117 at risk

Adverse event: Perforation, GIColon
Serious: yes
Organ System: Gastrointestinal disorders
Notes: GI/Colon Perforation
Frequency: 1 affected / 117 at risk

Adverse event: Constitutional Symptoms - Fever
Serious: yes
Organ System: General disorders
Notes: Fever (in the absence of neutropenia, where neutropenia is defined as ANC \<1.0 x 10eFever (in the absence of neutropenia, where neutropenia is defined as ANC \<1.0 x 10e9/L)9/L)
Frequency: 1 affected / 117 at risk

Adverse event: Hemorrhage, GI Lower
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 117 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory - Bronchopulmonary
Serious: yes
Organ System: General disorders
Notes: Hemorrhage, pulmonary/upper respiratory Bronchopulmonary
Frequency: 1 affected / 117 at risk

Adverse event: Pain- Chest/thorax
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 117 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Notes: Allergic reaction/hypersensitivity (including drug fever)
Frequency: 1 affected / 117 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 117 at risk

Adverse event: Infection - Wound
Serious: yes
Organ System: Infections and infestations
Notes: Infection with normal ANC or Grade 1 or 2 neutrophils Wound
Frequency: 1 affected / 117 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 117 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 117 at risk

Adverse event: Cerebrovascular Ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 117 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 117 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 117 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 117 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 117 at risk

Adverse event: Upper Respiratory - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 117 at risk

Adverse event: Wound complication, non-infectious
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 117 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 117 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 117 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Notes: Supraventricular and nodal arrhythmia Atrial fibrillation
Frequency: 1 affected / 117 at risk

Adverse event: Skin - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 117 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 117 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 117 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 117 at risk

Adverse event: Extrapyramidal/involuntary movement/restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 117 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 117 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 77 at risk

Adverse event: Cardiac General
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac General
Frequency: 2 affected / 77 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac ischemia/infarction
Frequency: 1 affected / 77 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 77 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Hemorrhage - Respiratory tract NOS
Serious: yes
Organ System: General disorders
Notes: Hemorrhage, pulmonary/upper respiratory/ Respiratory tract None otherwise specified (NOS)
Frequency: 1 affected / 77 at risk

Adverse event: Pain - Abdomen NOS
Serious: yes
Organ System: General disorders
Notes: None otherwise specified (NOW)
Frequency: 1 affected / 77 at risk

Adverse event: Pain - Bone
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 77 at risk

Adverse event: Pain - Other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 77 at risk

Adverse event: Infection - Foreign body
Serious: yes
Organ System: Infections and infestations
Notes: Infection with normal ANC or Grade 1 or 2 neutrophils Foreign body (e.g., graft, implant, prosthesis, stent)
Frequency: 2 affected / 77 at risk

Adverse event: Infection - Lung
Serious: yes
Organ System: Infections and infestations
Notes: Infection with normal ANC or Grade 1 or 2 neutrophils Lung (pneumonia)
Frequency: 4 affected / 77 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 77 at risk

Adverse event: Musculoskeletal / Soft Tissue - Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Musculoskeletal / Soft Tissue - Other
Frequency: 1 affected / 77 at risk

Adverse event: Neurology - Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 77 at risk

Adverse event: Obstruction - Ureter
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 77 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 77 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 77 at risk

Adverse event: Upper Respiratory - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 77 at risk

Adverse event: Thrombosis/embolism (vascular access-related)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 77 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 77 at risk

Adverse event: Constitutional symptoms - Fever
Serious: no
Organ System: General disorders
Notes: Fever (in the absence of neutropenia, where neutropenia is defined as ANC \<1.0 x 10e9/L)
Frequency: 1 affected / 77 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 77 at risk

Adverse event: Skin exfoliation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 77 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 77 at risk

Adverse event: Pain - Abdomen NOS
Serious: no
Organ System: General disorders
Notes: None otherwise specified (NOS)
Frequency: 1 affected / 77 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Upper respiratory - other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Notes: Thrombosis/ thrombus/ embolism
Frequency: 1 affected / 77 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Supraventricular and nodal arrhythmia
Frequency: 1 affected / 75 at risk

Adverse event: Cardiac General
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac General
Frequency: 2 affected / 75 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Fistula, Esophagus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Constitutional Symptoms- Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 75 at risk

Adverse event: Hemorrhage, pulmonary/upper respiratory- Lung
Serious: yes
Organ System: General disorders
Notes: Hemorrhage, pulmonary/upper respiratory- Lung
Frequency: 1 affected / 75 at risk

Adverse event: Colitis, Infectious
Serious: yes
Organ System: Infections and infestations
Notes: example: Clostridium difficile
Frequency: 1 affected / 75 at risk

Adverse event: Infection - Lung
Serious: yes
Organ System: Infections and infestations
Notes: Infection with normal ANC or Grade 1 or 2 neutrophils Lung (pneumonia)
Frequency: 1 affected / 75 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 75 at risk

Adverse event: Musculoskeletal / Soft Tissue - Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Musculoskeletal / Soft Tissue - Other
Frequency: 1 affected / 75 at risk

Adverse event: Cerebrovascular Ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 75 at risk

Adverse event: Neurology - Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 75 at risk

Adverse event: Pleural effusion (non-malignant)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Upper Respiratory - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 75 at risk

Adverse event: Intra-operative Injury - Other
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 75 at risk