Study: NCT00449033

Adverse event: Blood - Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 452 at risk

Adverse event: Bone marrow cellularity
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Edema: Limb
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 452 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 452 at risk

Adverse event: International normalised ratio
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Leukocytes
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 452 at risk

Adverse event: Neutrophil count
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 19 affected / 452 at risk

Adverse event: Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 63 affected / 452 at risk

Adverse event: Cardiac arrhythmia - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 452 at risk

Adverse event: Cardiac general - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 452 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 452 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 452 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 452 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 452 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 452 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 452 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 452 at risk

Adverse event: Supraventricular arrhythmia, Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 452 at risk

Adverse event: Supraventricular arrhythmia, Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 452 at risk

Adverse event: Supraventricular arrhythmia, Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 452 at risk

Adverse event: Ventricular arrhythmia, Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 452 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 452 at risk

Adverse event: Vitreous haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 452 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 452 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 452 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 452 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 452 at risk

Adverse event: GI - Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 452 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 452 at risk

Adverse event: Mucositis (functional/symptomatic), Esophagus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Mucositis (functional/symptomatic), Oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 452 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 452 at risk

Adverse event: Obstruction, GI, Colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Obstruction, GI, Gallbladder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Perforation, GI, Colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Perforation, GI, Stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Stricture, GI, Esophagus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 452 at risk

Adverse event: Constitutional symptoms - Other
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 452 at risk

Adverse event: Death not associated with CTCAE term, Death NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Death not associated with CTCAE term, Disease progression NOS
Serious: yes
Organ System: General disorders
Frequency: 21 affected / 452 at risk

Adverse event: Death not associated with CTCAE term, Multi-Organ Failure
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 452 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 452 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 14 affected / 452 at risk

Adverse event: No code in CTCAE
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Pain, Abdomen NOS
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 452 at risk

Adverse event: Pain, Back
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 452 at risk

Adverse event: Pain, Bone
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 452 at risk

Adverse event: Pain, Chest wall
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Pain, Chest/Thorax NOS
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 452 at risk

Adverse event: Pain, Gallbladder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Pain, Head/Headache
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 452 at risk

Adverse event: Pain, Other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 452 at risk

Adverse event: Pain, Pelvis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Pain, Stomach
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Pain, Tumor pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 452 at risk

Adverse event: Tumour lysis syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 452 at risk

Adverse event: Hepatobiliary - Other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 452 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 452 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 452 at risk

Adverse event: Infection (Documented clinically), Bladder (urinary)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 452 at risk

Adverse event: Infection (Documented clinically), Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 452 at risk

Adverse event: Infection (Documented clinically), Kidney
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 452 at risk

Adverse event: Infection (Documented clinically), Lung (Pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 452 at risk

Adverse event: Infection (Documented clinically), Upper airway NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 452 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 452 at risk

Adverse event: Infection with normal ANC, Abdomen NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 452 at risk

Adverse event: Infection with normal ANC, Anal/perianal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 452 at risk

Adverse event: Infection with normal ANC, Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 452 at risk

Adverse event: Infection with normal ANC, Bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 452 at risk

Adverse event: Infection with normal ANC, Catheter-related
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 452 at risk

Adverse event: Infection with normal ANC, Lung (Pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 22 affected / 452 at risk

Adverse event: Infection with normal ANC, Meninges (Meningitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 452 at risk

Adverse event: Infection with normal ANC, Skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 452 at risk

Adverse event: Infection with normal ANC, Soft tissue NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 452 at risk

Adverse event: Infection with normal ANC, Urinary tract NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 452 at risk

Adverse event: Infection with unknown ANC, Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 452 at risk

Adverse event: Infection with unknown ANC, Lung (Pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 452 at risk

Adverse event: Infection with unknown ANC, Pleura (Empyema)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 452 at risk

Adverse event: Infection with unknown ANC, Soft tissue NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 452 at risk

Adverse event: Infection with unknown ANC, Wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 452 at risk

Adverse event: Intraop injury, Jejunum
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 452 at risk

Adverse event: Intraop injury, Lung
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 452 at risk

Adverse event: Alanine aminotransferase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 452 at risk

Adverse event: Bilirubin (Hyperbilirubinemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 452 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 452 at risk

Adverse event: Glomerular filtration rate
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 452 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 452 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 452 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 452 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 452 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 452 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 452 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 452 at risk

Adverse event: Muscle weakness, Extremity - lower
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 452 at risk

Adverse event: Muscle weakness, Whole body/generalized
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 452 at risk

Adverse event: Musculoskeletal - Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 452 at risk

Adverse event: Osteoporosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 452 at risk

Adverse event: CNS ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 452 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Neurology - Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Neuropathy: motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Personality
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 452 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 452 at risk

Adverse event: Syncope (Fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 452 at risk

Adverse event: Tremor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 452 at risk

Adverse event: Renal - Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 452 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 452 at risk

Adverse event: Airway obstruction, Bronchus
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 452 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 452 at risk

Adverse event: Dyspnea (Shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 452 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 452 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 452 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 452 at risk

Adverse event: Pulmonary - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 452 at risk

Adverse event: Dermatology - Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 452 at risk

Adverse event: Erythema multiforme
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 452 at risk

Adverse event: Hand-foot skin reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 452 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 452 at risk

Adverse event: Artery injury, Aorta
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 452 at risk

Adverse event: CNS hemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 452 at risk

Adverse event: Hemorrhage - Other
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 452 at risk

Adverse event: Hemorrhage pulmonary, Bronchopulmonary NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 452 at risk

Adverse event: Hemorrhage pulmonary, Lung
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 452 at risk

Adverse event: Hemorrhage pulmonary, Nose
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 452 at risk

Adverse event: Hemorrhage pulmonary, Respiratory tract NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 452 at risk

Adverse event: Hemorrhage, GI, Abdomen NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 452 at risk

Adverse event: Hemorrhage, GI, Anus
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 452 at risk

Adverse event: Hemorrhage, GI, Colon
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 452 at risk

Adverse event: Hemorrhage, GI, Duodenum
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 452 at risk

Adverse event: Hemorrhage, GI, Rectum
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 452 at risk

Adverse event: Hemorrhage, GI, Stomach
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 452 at risk

Adverse event: Hemorrhage, GI, Upper GI NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 452 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 452 at risk

Adverse event: Thrombosis/Embolism (vascular access)
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 452 at risk

Adverse event: Thrombosis/Thrombus/Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 26 affected / 452 at risk

Adverse event: Vascular - Other
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 452 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 452 at risk

Adverse event: Blood - Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 452 at risk

Adverse event: Edema: Limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 452 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 214 affected / 452 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 158 affected / 452 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 30 affected / 452 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 210 affected / 452 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 255 affected / 452 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 76 affected / 452 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 24 affected / 452 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 177 affected / 452 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 148 affected / 452 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 189 affected / 452 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 452 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 452 at risk

Adverse event: Mucositis (functional/symptomatic), Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 114 affected / 452 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 263 affected / 452 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 452 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 199 affected / 452 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 242 affected / 452 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 67 affected / 452 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 51 affected / 452 at risk

Adverse event: Pain, Abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 61 affected / 452 at risk

Adverse event: Pain, Back
Serious: no
Organ System: General disorders
Frequency: 46 affected / 452 at risk

Adverse event: Pain, Chest/Thorax NOS
Serious: no
Organ System: General disorders
Frequency: 54 affected / 452 at risk

Adverse event: Pain, Extremity - limb
Serious: no
Organ System: General disorders
Frequency: 32 affected / 452 at risk

Adverse event: Pain, Head/Headache
Serious: no
Organ System: General disorders
Frequency: 54 affected / 452 at risk

Adverse event: Pain, Joint
Serious: no
Organ System: General disorders
Frequency: 24 affected / 452 at risk

Adverse event: Pain, Muscle
Serious: no
Organ System: General disorders
Frequency: 24 affected / 452 at risk

Adverse event: Pain, Stomach
Serious: no
Organ System: General disorders
Frequency: 27 affected / 452 at risk

Adverse event: Pain, Throat/Pharynx/Larynx
Serious: no
Organ System: General disorders
Frequency: 23 affected / 452 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 55 affected / 452 at risk

Adverse event: Infection with normal ANC, Upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 452 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 452 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 452 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 452 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 49 affected / 452 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 75 affected / 452 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 67 affected / 452 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 49 affected / 452 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 31 affected / 452 at risk

Adverse event: Metabolic/Lab - Other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 37 affected / 452 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 55 affected / 452 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 71 affected / 452 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 80 affected / 452 at risk

Adverse event: Dyspnea (Shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 92 affected / 452 at risk

Adverse event: Voice changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 34 affected / 452 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 148 affected / 452 at risk

Adverse event: Dermatology - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 25 affected / 452 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 32 affected / 452 at risk

Adverse event: Hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 121 affected / 452 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 36 affected / 452 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 165 affected / 452 at risk

Adverse event: Hemorrhage pulmonary, Nose
Serious: no
Organ System: Vascular disorders
Frequency: 78 affected / 452 at risk

Adverse event: Blood - Other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 449 at risk

Adverse event: Edema: Head and Neck
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 449 at risk

Adverse event: Edema: Limb
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 449 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 449 at risk

Adverse event: Leukocytes
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 449 at risk

Adverse event: Neutrophil count
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 449 at risk

Adverse event: Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 27 affected / 449 at risk

Adverse event: Cardiac general - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 449 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 449 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 449 at risk

Adverse event: Conduction abnormality, Conduction abnormality NOS
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 449 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 449 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 449 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 449 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 449 at risk

Adverse event: Supraventricular arrhythmia, Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 449 at risk

Adverse event: Ventricular arrhythmia, Ventricular arrhythmia NOS
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 449 at risk

Adverse event: Endocrine - Other
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 449 at risk

Adverse event: Optic disc edema
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 449 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 449 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 449 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 449 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 449 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 449 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 449 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 449 at risk

Adverse event: Obstruction, GI, Colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 449 at risk

Adverse event: Obstruction, GI, Ileum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 449 at risk

Adverse event: Stricture, GI, Colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 449 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 449 at risk

Adverse event: Constitutional symptoms - Other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 449 at risk

Adverse event: Death not associated with CTCAE term, Death NOS
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 449 at risk

Adverse event: Death not associated with CTCAE term, Disease progression NOS
Serious: yes
Organ System: General disorders
Frequency: 15 affected / 449 at risk

Adverse event: Death not associated with CTCAE term, Multi-Organ Failure
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 449 at risk

Adverse event: Death not associated with CTCAE term, Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 449 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 449 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 449 at risk

Adverse event: Hypothermia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 449 at risk

Adverse event: No code in CTCAE
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 449 at risk

Adverse event: Pain, Abdomen NOS
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 449 at risk

Adverse event: Pain, Back
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 449 at risk

Adverse event: Pain, Bone
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 449 at risk

Adverse event: Pain, Chest wall
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 449 at risk

Adverse event: Pain, Chest/Thorax NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 449 at risk

Adverse event: Pain, Extremity - limb
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 449 at risk

Adverse event: Pain, Neuralgia/Peripheral nerve
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 449 at risk

Adverse event: Pain, Tumor pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 449 at risk

Adverse event: Liver dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 449 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 449 at risk

Adverse event: Infection (Documented clinically), Bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 449 at risk

Adverse event: Infection (Documented clinically), Lung (Pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 449 at risk

Adverse event: Infection (Documented clinically), Pleura (Empyema)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 449 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 449 at risk

Adverse event: Infection with normal ANC, Abdomen NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 449 at risk

Adverse event: Infection with normal ANC, Bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 449 at risk

Adverse event: Infection with normal ANC, Lung (Pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 449 at risk

Adverse event: Infection with normal ANC, Scrotum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 449 at risk

Adverse event: Infection with unknown ANC, Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 449 at risk

Adverse event: Infection with unknown ANC, Lung (Pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 449 at risk

Adverse event: Intraop injury, Lung
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 449 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 449 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 449 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 449 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 449 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 449 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 449 at risk

Adverse event: Soft tissue necrosis, Extremity - lower
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 449 at risk

Adverse event: CNS ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 449 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 449 at risk

Adverse event: Mood alteration, Depression
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 449 at risk

Adverse event: Neurology - Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 449 at risk

Adverse event: Neuropathy: Cranial, CN II Vision
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 449 at risk

Adverse event: Neuropathy: sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 449 at risk

Adverse event: Pyramidal tract dysfunction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 449 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 449 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 449 at risk

Adverse event: Speech impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 449 at risk

Adverse event: Syncope (Fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 449 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 449 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 449 at risk

Adverse event: Airway obstruction, Bronchus
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 449 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 449 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 449 at risk

Adverse event: Dyspnea (Shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 449 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 449 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 449 at risk

Adverse event: Pulmonary - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 449 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 449 at risk

Adverse event: CNS hemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 449 at risk

Adverse event: Hemorrhage pulmonary, Bronchopulmonary NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 449 at risk

Adverse event: Hemorrhage pulmonary, Lung
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 449 at risk

Adverse event: Hemorrhage pulmonary, Nose
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 449 at risk

Adverse event: Hemorrhage, GI, Anus
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 449 at risk

Adverse event: Hemorrhage, GI, Stomach
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 449 at risk

Adverse event: Hemorrhage, GI, Upper GI NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 449 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 449 at risk

Adverse event: Phlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 449 at risk

Adverse event: Thrombosis/Embolism (vascular access)
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 449 at risk

Adverse event: Thrombosis/Thrombus/Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 22 affected / 449 at risk

Adverse event: Vascular - Other
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 449 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 449 at risk

Adverse event: Blood - Other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 34 affected / 449 at risk

Adverse event: Edema: Limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 39 affected / 449 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 221 affected / 449 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 146 affected / 449 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 449 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 225 affected / 449 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 210 affected / 449 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 34 affected / 449 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 34 affected / 449 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 158 affected / 449 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 133 affected / 449 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 80 affected / 449 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 449 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 449 at risk

Adverse event: Mucositis (functional/symptomatic), Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 50 affected / 449 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 247 affected / 449 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 449 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 198 affected / 449 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 237 affected / 449 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 59 affected / 449 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 55 affected / 449 at risk

Adverse event: Pain, Abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 42 affected / 449 at risk

Adverse event: Pain, Back
Serious: no
Organ System: General disorders
Frequency: 37 affected / 449 at risk

Adverse event: Pain, Chest/Thorax NOS
Serious: no
Organ System: General disorders
Frequency: 64 affected / 449 at risk

Adverse event: Pain, Extremity - limb
Serious: no
Organ System: General disorders
Frequency: 35 affected / 449 at risk

Adverse event: Pain, Head/Headache
Serious: no
Organ System: General disorders
Frequency: 43 affected / 449 at risk

Adverse event: Pain, Joint
Serious: no
Organ System: General disorders
Frequency: 25 affected / 449 at risk

Adverse event: Pain, Muscle
Serious: no
Organ System: General disorders
Frequency: 18 affected / 449 at risk

Adverse event: Pain, Stomach
Serious: no
Organ System: General disorders
Frequency: 28 affected / 449 at risk

Adverse event: Pain, Throat/Pharynx/Larynx
Serious: no
Organ System: General disorders
Frequency: 10 affected / 449 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 31 affected / 449 at risk

Adverse event: Infection with normal ANC, Upper airway NOS
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 449 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 449 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 449 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 39 affected / 449 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 449 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 43 affected / 449 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 55 affected / 449 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 44 affected / 449 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 449 at risk

Adverse event: Metabolic/Lab - Other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 44 affected / 449 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 46 affected / 449 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 77 affected / 449 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 106 affected / 449 at risk

Adverse event: Dyspnea (Shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 86 affected / 449 at risk

Adverse event: Voice changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 449 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 74 affected / 449 at risk

Adverse event: Dermatology - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 449 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 449 at risk

Adverse event: Hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 449 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 449 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 93 affected / 449 at risk

Adverse event: Hemorrhage pulmonary, Nose
Serious: no
Organ System: Vascular disorders
Frequency: 33 affected / 449 at risk