Study: NCT00863746

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 346 at risk

Adverse event: Neutrophil count
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 346 at risk

Adverse event: Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 346 at risk

Adverse event: Cardiac general - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 346 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 346 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 346 at risk

Adverse event: Conduction abnormality, AV Block - 3rd Degree (Complete AV Block)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 346 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 346 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 346 at risk

Adverse event: Supraventricular arrhythmia, Atrial Tach/Paroxysmal AT
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 346 at risk

Adverse event: Supraventricular arrhythmia, Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 346 at risk

Adverse event: Auditory/Ear - Other
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 346 at risk

Adverse event: Ocular - Other
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 346 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 346 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 346 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 346 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 346 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 346 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 346 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 346 at risk

Adverse event: Mucositis (functional/symptomatic), Oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 346 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 346 at risk

Adverse event: Stricture, GI, Esophagus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 346 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 346 at risk

Adverse event: Constitutional symptoms - Other
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 346 at risk

Adverse event: Death not associated with CTCAE term, Death NOS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 346 at risk

Adverse event: Death not associated with CTCAE term, Disease progression NOS
Serious: yes
Organ System: General disorders
Frequency: 20 affected / 346 at risk

Adverse event: Death not associated with CTCAE term, Multi-Organ Failure
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 346 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 346 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 346 at risk

Adverse event: Pain, Abdomen NOS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 346 at risk

Adverse event: Pain, Back
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 346 at risk

Adverse event: Pain, Bone
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 346 at risk

Adverse event: Pain, Chest wall
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 346 at risk

Adverse event: Pain, Chest/Thorax NOS
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 346 at risk

Adverse event: Pain, Pain NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 346 at risk

Adverse event: Pain, Tumor pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 346 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 346 at risk

Adverse event: Hepatobiliary - Other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 346 at risk

Adverse event: Liver dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 346 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 346 at risk

Adverse event: Infection (Documented clinically), Lung (Pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 346 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 346 at risk

Adverse event: Infection with normal ANC, Bone (Osteomyelitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 346 at risk

Adverse event: Infection with normal ANC, Brain (Encephalitis, infectious)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 346 at risk

Adverse event: Infection with normal ANC, Bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 346 at risk

Adverse event: Infection with normal ANC, Lung (Pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 346 at risk

Adverse event: Infection with normal ANC, Skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 346 at risk

Adverse event: Infection with normal ANC, Upper airway NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 346 at risk

Adverse event: Infection with unknown ANC, Lung (Pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 346 at risk

Adverse event: Infection with unknown ANC, Upper airway NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 346 at risk

Adverse event: Acidosis (metabolic or respiratory)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 346 at risk

Adverse event: Hyperuricaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 346 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 346 at risk

Adverse event: Device/Prosthesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 346 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 346 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 346 at risk

Adverse event: CNS ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 346 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 346 at risk

Adverse event: Neurology - Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 346 at risk

Adverse event: Neuropathy: sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 346 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 346 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 346 at risk

Adverse event: Speech impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 346 at risk

Adverse event: Renal - Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 346 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 346 at risk

Adverse event: Chest tube drainage or leak
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 346 at risk

Adverse event: Dyspnea (Shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 35 affected / 346 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 346 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 346 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 346 at risk

Adverse event: Pulmonary - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 346 at risk

Adverse event: Hand-foot skin reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 346 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 346 at risk

Adverse event: CNS hemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 346 at risk

Adverse event: Hemorrhage pulmonary, Bronchopulmonary NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 346 at risk

Adverse event: Hemorrhage pulmonary, Lung
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 346 at risk

Adverse event: Hemorrhage, GI, Abdomen NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 346 at risk

Adverse event: Thrombosis/Embolism (vascular access)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 346 at risk

Adverse event: Thrombosis/Thrombus/Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 346 at risk

Adverse event: Vascular - Other
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 346 at risk

Adverse event: Pain, Head/Headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 346 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 346 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 68 affected / 346 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 104 affected / 346 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 49 affected / 346 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 123 affected / 346 at risk

Adverse event: Mucositis (functional/symptomatic), Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 58 affected / 346 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 58 affected / 346 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 51 affected / 346 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 125 affected / 346 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 39 affected / 346 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 30 affected / 346 at risk

Adverse event: Pain, Abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 34 affected / 346 at risk

Adverse event: Pain, Back
Serious: no
Organ System: General disorders
Frequency: 33 affected / 346 at risk

Adverse event: Pain, Bone
Serious: no
Organ System: General disorders
Frequency: 19 affected / 346 at risk

Adverse event: Pain, Chest wall
Serious: no
Organ System: General disorders
Frequency: 23 affected / 346 at risk

Adverse event: Pain, Chest/Thorax NOS
Serious: no
Organ System: General disorders
Frequency: 44 affected / 346 at risk

Adverse event: Pain, Extremity - limb
Serious: no
Organ System: General disorders
Frequency: 25 affected / 346 at risk

Adverse event: Pain, Head/Headache
Serious: no
Organ System: General disorders
Frequency: 38 affected / 346 at risk

Adverse event: Pain, Joint
Serious: no
Organ System: General disorders
Frequency: 30 affected / 346 at risk

Adverse event: Pain, Muscle
Serious: no
Organ System: General disorders
Frequency: 18 affected / 346 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 43 affected / 346 at risk

Adverse event: Infection with normal ANC, Upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 346 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 26 affected / 346 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 346 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 346 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 346 at risk

Adverse event: Metabolic/Lab - Other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 346 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 346 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 346 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 346 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 79 affected / 346 at risk

Adverse event: Dyspnea (Shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 83 affected / 346 at risk

Adverse event: Voice changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 346 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 65 affected / 346 at risk

Adverse event: Hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 190 affected / 346 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 346 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 140 affected / 346 at risk

Adverse event: Edema: Limb
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 351 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 351 at risk

Adverse event: International normalised ratio
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 351 at risk

Adverse event: Leukocytes
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 351 at risk

Adverse event: Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 351 at risk

Adverse event: Cardiac general - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 351 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 351 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 351 at risk

Adverse event: Supraventricular arrhythmia, Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 351 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 351 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 351 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 351 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 351 at risk

Adverse event: GI - Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 351 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 351 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 351 at risk

Adverse event: Obstruction, GI, Small bowel NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 351 at risk

Adverse event: Stricture, GI, Biliary tree
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 351 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 351 at risk

Adverse event: Constitutional symptoms - Other
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 351 at risk

Adverse event: Death not associated with CTCAE term, Disease progression NOS
Serious: yes
Organ System: General disorders
Frequency: 13 affected / 351 at risk

Adverse event: Death not associated with CTCAE term, Multi-Organ Failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 351 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 351 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 351 at risk

Adverse event: Pain, Abdomen NOS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 351 at risk

Adverse event: Pain, Back
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 351 at risk

Adverse event: Pain, Bone
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 351 at risk

Adverse event: Pain, Chest wall
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 351 at risk

Adverse event: Pain, Chest/Thorax NOS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 351 at risk

Adverse event: Pain, Extremity - limb
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 351 at risk

Adverse event: Pain, Tumor pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 351 at risk

Adverse event: Hepatobiliary - Other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 351 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 351 at risk

Adverse event: Infection (Documented clinically), Lung (Pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 351 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 351 at risk

Adverse event: Infection with normal ANC, Bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 351 at risk

Adverse event: Infection with normal ANC, Lung (Pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 351 at risk

Adverse event: Infection with normal ANC, Upper airway NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 351 at risk

Adverse event: Infection with unknown ANC, Lung (Pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 351 at risk

Adverse event: Infection with unknown ANC, Upper airway NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 351 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 351 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 351 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 351 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 351 at risk

Adverse event: Muscle weakness, Extremity - lower
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 351 at risk

Adverse event: Muscle weakness, Extremity - upper
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 351 at risk

Adverse event: CNS ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 351 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 351 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 351 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 351 at risk

Adverse event: Neurology - Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 351 at risk

Adverse event: Neuropathy: motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 351 at risk

Adverse event: Neuropathy: sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 351 at risk

Adverse event: Pyramidal tract dysfunction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 351 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 351 at risk

Adverse event: Syncope (Fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 351 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 351 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 351 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 351 at risk

Adverse event: Dyspnea (Shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 351 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 351 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 351 at risk

Adverse event: Pulmonary - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 351 at risk

Adverse event: Dermatology - Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 351 at risk

Adverse event: Hemorrhage, GI, Rectum
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 351 at risk

Adverse event: Thrombosis/Thrombus/Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 351 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 351 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 16 affected / 351 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 61 affected / 351 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 351 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 351 at risk

Adverse event: Mucositis (functional/symptomatic), Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 351 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 56 affected / 351 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 44 affected / 351 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 97 affected / 351 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 18 affected / 351 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 20 affected / 351 at risk

Adverse event: Pain, Abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 12 affected / 351 at risk

Adverse event: Pain, Back
Serious: no
Organ System: General disorders
Frequency: 37 affected / 351 at risk

Adverse event: Pain, Bone
Serious: no
Organ System: General disorders
Frequency: 28 affected / 351 at risk

Adverse event: Pain, Chest wall
Serious: no
Organ System: General disorders
Frequency: 18 affected / 351 at risk

Adverse event: Pain, Chest/Thorax NOS
Serious: no
Organ System: General disorders
Frequency: 32 affected / 351 at risk

Adverse event: Pain, Extremity - limb
Serious: no
Organ System: General disorders
Frequency: 20 affected / 351 at risk

Adverse event: Pain, Head/Headache
Serious: no
Organ System: General disorders
Frequency: 26 affected / 351 at risk

Adverse event: Pain, Joint
Serious: no
Organ System: General disorders
Frequency: 22 affected / 351 at risk

Adverse event: Pain, Muscle
Serious: no
Organ System: General disorders
Frequency: 14 affected / 351 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 17 affected / 351 at risk

Adverse event: Infection with normal ANC, Upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 351 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 351 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 351 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 351 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 351 at risk

Adverse event: Metabolic/Lab - Other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 351 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 351 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 351 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 351 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 67 affected / 351 at risk

Adverse event: Dyspnea (Shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 86 affected / 351 at risk

Adverse event: Voice changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 351 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 351 at risk

Adverse event: Hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 351 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 351 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 43 affected / 351 at risk