Study: NCT00105443

Adverse event: Neutrophil count
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 297 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 297 at risk

Adverse event: leukocytes
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 297 at risk

Adverse event: supraventricular arrhythmia, atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 297 at risk

Adverse event: supraventricular arrhythmia, sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 297 at risk

Adverse event: International normalised ratio
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 297 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 297 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 297 at risk

Adverse event: cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 297 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 297 at risk

Adverse event: Right ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 297 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 297 at risk

Adverse event: death not associated with ctcae term, death nos
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 297 at risk

Adverse event: death not associated with ctcae term, disease progression nos
Serious: yes
Organ System: General disorders
Frequency: 56 affected / 297 at risk

Adverse event: death not associated with ctcae term, multi-organ failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 297 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 297 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 297 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 297 at risk

Adverse event: constitutional symptoms - other
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 297 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 297 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 297 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 297 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 297 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 297 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 297 at risk

Adverse event: gi - other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 297 at risk

Adverse event: perforation, gi, colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 297 at risk

Adverse event: ulcer, gi, stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 297 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 297 at risk

Adverse event: cns hemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 297 at risk

Adverse event: hemorrhage, gi, abdomen nos
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 297 at risk

Adverse event: hemorrhage, gi, colon
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 297 at risk

Adverse event: hemorrhage, gi, duodenum
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 297 at risk

Adverse event: hemorrhage, gi, esophagus
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 297 at risk

Adverse event: hemorrhage, gi, varices (esophageal)
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 297 at risk

Adverse event: hemorrhage, gi, stomach
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 297 at risk

Adverse event: hemorrhage, gi, liver
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 297 at risk

Adverse event: hemorrhage, gi, varices (rectal)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 297 at risk

Adverse event: hemorrhage, gi, upper gi nos
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 297 at risk

Adverse event: hemorrhage - other
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 297 at risk

Adverse event: hemorrhage pulmonary, lung
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 297 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 297 at risk

Adverse event: liver dysfunction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 297 at risk

Adverse event: hepatobiliary - other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 297 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 297 at risk

Adverse event: infection (documented clinically), abdomen nos
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 297 at risk

Adverse event: infection (documented clinically), anal/perianal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 297 at risk

Adverse event: infection (documented clinically), lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 297 at risk

Adverse event: infection (documented clinically), skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 297 at risk

Adverse event: infection (documented clinically), upper airway nos
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 297 at risk

Adverse event: infection (documented clinically), urinary tract nos
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 297 at risk

Adverse event: infection with normal anc, gallbladder (cholecystitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 297 at risk

Adverse event: infection with unknown anc, biliary tree
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 297 at risk

Adverse event: infection with unknown anc, peritoneal cavity
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 297 at risk

Adverse event: infection with unknown anc, wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 297 at risk

Adverse event: edema: limb
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 297 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 297 at risk

Adverse event: musculoskeletal - other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 297 at risk

Adverse event: Aspartate aminotransferase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 297 at risk

Adverse event: Blood creatine phosphokinase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 297 at risk

Adverse event: bilirubin (hyperbilirubinemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 297 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 297 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 297 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 297 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 297 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 297 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 297 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 297 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 297 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 297 at risk

Adverse event: mood alteration, depression
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 297 at risk

Adverse event: neuropathy: motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 297 at risk

Adverse event: neuropathy: sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 297 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 297 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 297 at risk

Adverse event: syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 297 at risk

Adverse event: pain, back
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 297 at risk

Adverse event: pain, extremity-limb
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 297 at risk

Adverse event: pain, tumor pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 297 at risk

Adverse event: pain, abdomen nos
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 297 at risk

Adverse event: pain, joint
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 297 at risk

Adverse event: pain, bone
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 297 at risk

Adverse event: pain, other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 297 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 297 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 297 at risk

Adverse event: dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 297 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 297 at risk

Adverse event: hand-foot skin reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 297 at risk

Adverse event: dermatology - other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 297 at risk

Adverse event: intraop injury, biliary tree - common bile duct
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 297 at risk

Adverse event: syndromes - other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 297 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 297 at risk

Adverse event: thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 297 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 297 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 25 affected / 297 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 27 affected / 297 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 29 affected / 297 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 21 affected / 297 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 133 affected / 297 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 89 affected / 297 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 83 affected / 297 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 61 affected / 297 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 297 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 158 affected / 297 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 297 at risk

Adverse event: mucositis (functional/symptomatic), oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 297 at risk

Adverse event: mucositis (clinical exam), oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 297 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 71 affected / 297 at risk

Adverse event: gi - other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 297 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 297 at risk

Adverse event: liver dysfunction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 297 at risk

Adverse event: edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 45 affected / 297 at risk

Adverse event: musculoskeletal - other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 297 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 297 at risk

Adverse event: bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 297 at risk

Adverse event: pain, back
Serious: no
Organ System: General disorders
Frequency: 36 affected / 297 at risk

Adverse event: pain, abdomen nos
Serious: no
Organ System: General disorders
Frequency: 91 affected / 297 at risk

Adverse event: pain, head/headache
Serious: no
Organ System: General disorders
Frequency: 26 affected / 297 at risk

Adverse event: pain, joint
Serious: no
Organ System: General disorders
Frequency: 20 affected / 297 at risk

Adverse event: pain, stomach
Serious: no
Organ System: General disorders
Frequency: 21 affected / 297 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 297 at risk

Adverse event: dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 297 at risk

Adverse event: voice changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 27 affected / 297 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 42 affected / 297 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 31 affected / 297 at risk

Adverse event: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 63 affected / 297 at risk

Adverse event: dermatology - other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 297 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 40 affected / 297 at risk

Adverse event: rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 55 affected / 297 at risk

Adverse event: platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 297 at risk

Adverse event: constitutional symptoms - other
Serious: no
Organ System: General disorders
Frequency: 7 affected / 297 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 297 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 297 at risk

Adverse event: hepatobiliary - other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 297 at risk

Adverse event: infection - other
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 297 at risk

Adverse event: mood alteration, depression
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 297 at risk

Adverse event: pain, bone
Serious: no
Organ System: General disorders
Frequency: 12 affected / 297 at risk

Adverse event: pain, liver
Serious: no
Organ System: General disorders
Frequency: 12 affected / 297 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 297 at risk

Adverse event: flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 8 affected / 297 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 302 at risk

Adverse event: supraventricular arrhythmia, atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 302 at risk

Adverse event: conduction abnormality, av block - first degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 302 at risk

Adverse event: ventricular arrhythmia, ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 302 at risk

Adverse event: ventricular arrhythmia, ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 302 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 302 at risk

Adverse event: cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 302 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 302 at risk

Adverse event: cardiac general - other
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 302 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 302 at risk

Adverse event: death not associated with ctcae term, death nos
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 302 at risk

Adverse event: death not associated with ctcae term, disease progression nos
Serious: yes
Organ System: General disorders
Frequency: 61 affected / 302 at risk

Adverse event: death not associated with ctcae term, sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 302 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 302 at risk

Adverse event: Insomnia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 302 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 302 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 302 at risk

Adverse event: constitutional symptoms - other
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 302 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 302 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 302 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 302 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 302 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 302 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 302 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 302 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 302 at risk

Adverse event: stricture, gi, biliary tree
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 302 at risk

Adverse event: ulcer, gi, duodenum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 302 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 302 at risk

Adverse event: cns hemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 302 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 302 at risk

Adverse event: hemorrhage, gi, abdomen nos
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 302 at risk

Adverse event: hemorrhage, gi, duodenum
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 302 at risk

Adverse event: hemorrhage, gi, esophagus
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 302 at risk

Adverse event: hemorrhage, gi, varices (esophageal)
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 302 at risk

Adverse event: hemorrhage, gi, stomach
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 302 at risk

Adverse event: hemorrhage, gi, liver
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 302 at risk

Adverse event: hemorrhage, gi, lower gi nos
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 302 at risk

Adverse event: hemorrhage, gi, oral cavity
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 302 at risk

Adverse event: hemorrhage, gi, peritoneal cavity
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 302 at risk

Adverse event: hemorrhage, gi, upper gi nos
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 302 at risk

Adverse event: hemorrhage with surgery
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 302 at risk

Adverse event: hemorrhage - other
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 302 at risk

Adverse event: hemorrhage pulmonary, pleura
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 302 at risk

Adverse event: liver dysfunction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 302 at risk

Adverse event: hepatobiliary - other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 302 at risk

Adverse event: infection (documented clinically), biliary tree
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 302 at risk

Adverse event: infection (documented clinically), lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 302 at risk

Adverse event: infection (documented clinically), skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 302 at risk

Adverse event: infection (documented clinically), soft tissue nos
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 302 at risk

Adverse event: infection with normal anc, bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 302 at risk

Adverse event: infection with normal anc, oral cavity-gums (gingivitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 302 at risk

Adverse event: infection with normal anc, peritoneal cavity
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 302 at risk

Adverse event: infection with normal anc, skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 302 at risk

Adverse event: infection with normal anc, urinary tract nos
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 302 at risk

Adverse event: infection - other
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 302 at risk

Adverse event: infection with unknown anc, lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 302 at risk

Adverse event: infection with unknown anc, peritoneal cavity
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 302 at risk

Adverse event: infection with unknown anc, urinary tract nos
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 302 at risk

Adverse event: lymphatics - other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 302 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 302 at risk

Adverse event: musculoskeletal - other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 302 at risk

Adverse event: device/prosthesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 302 at risk

Adverse event: muscle weakness, whole body/generalized
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 302 at risk

Adverse event: Alanine aminotransferase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 302 at risk

Adverse event: Aspartate aminotransferase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 302 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 302 at risk

Adverse event: Gamma-glutamyltransferase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 302 at risk

Adverse event: bilirubin (hyperbilirubinemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 302 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 302 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 302 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 302 at risk

Adverse event: cns ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 302 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 302 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 302 at risk

Adverse event: neuropathy: motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 302 at risk

Adverse event: neurology - other
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 302 at risk

Adverse event: neuropathy: sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 302 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 302 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 302 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 302 at risk

Adverse event: pain, back
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 302 at risk

Adverse event: pain, tumor pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 302 at risk

Adverse event: pain, abdomen nos
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 302 at risk

Adverse event: pain, bone
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 302 at risk

Adverse event: pain, liver
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 302 at risk

Adverse event: pain, neuralgia/peripheral nerve
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 302 at risk

Adverse event: pain, stomach
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 302 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 302 at risk

Adverse event: hiccoughs
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 302 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 302 at risk

Adverse event: pulmonary - other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 302 at risk

Adverse event: dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 302 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 302 at risk

Adverse event: obstruction, gu, ureter
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 302 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 302 at risk

Adverse event: thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 302 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 302 at risk

Adverse event: not coded yet
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 302 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 302 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 302 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 28 affected / 302 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 22 affected / 302 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 132 affected / 302 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 28 affected / 302 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 52 affected / 302 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 67 affected / 302 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 302 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 74 affected / 302 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 302 at risk

Adverse event: mucositis (functional/symptomatic), oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 302 at risk

Adverse event: mucositis (clinical exam), oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 302 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 58 affected / 302 at risk

Adverse event: gi - other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 302 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 302 at risk

Adverse event: liver dysfunction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 302 at risk

Adverse event: edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 53 affected / 302 at risk

Adverse event: musculoskeletal - other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 302 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 302 at risk

Adverse event: bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 302 at risk

Adverse event: pain, back
Serious: no
Organ System: General disorders
Frequency: 38 affected / 302 at risk

Adverse event: pain, abdomen nos
Serious: no
Organ System: General disorders
Frequency: 74 affected / 302 at risk

Adverse event: pain, head/headache
Serious: no
Organ System: General disorders
Frequency: 25 affected / 302 at risk

Adverse event: pain, joint
Serious: no
Organ System: General disorders
Frequency: 26 affected / 302 at risk

Adverse event: pain, stomach
Serious: no
Organ System: General disorders
Frequency: 20 affected / 302 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 302 at risk

Adverse event: dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 302 at risk

Adverse event: voice changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 302 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 302 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 302 at risk

Adverse event: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 302 at risk

Adverse event: dermatology - other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 302 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 33 affected / 302 at risk

Adverse event: rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 42 affected / 302 at risk

Adverse event: platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 302 at risk

Adverse event: constitutional symptoms - other
Serious: no
Organ System: General disorders
Frequency: 10 affected / 302 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 302 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 302 at risk

Adverse event: hepatobiliary - other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 302 at risk

Adverse event: infection - other
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 302 at risk

Adverse event: mood alteration, depression
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 302 at risk

Adverse event: pain, bone
Serious: no
Organ System: General disorders
Frequency: 13 affected / 302 at risk

Adverse event: pain, liver
Serious: no
Organ System: General disorders
Frequency: 13 affected / 302 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 302 at risk

Adverse event: flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 7 affected / 302 at risk

Adverse event: Neutrophil count
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 297 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 297 at risk

Adverse event: leukocytes
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 297 at risk

Adverse event: supraventricular arrhythmia, atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 297 at risk

Adverse event: supraventricular arrhythmia, sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 297 at risk

Adverse event: International normalised ratio
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 297 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 297 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 297 at risk

Adverse event: cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 297 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 297 at risk

Adverse event: Right ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 297 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 297 at risk

Adverse event: death not associated with ctcae term, death nos
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 297 at risk

Adverse event: death not associated with ctcae term, disease progression nos
Serious: yes
Organ System: General disorders
Frequency: 68 affected / 297 at risk

Adverse event: death not associated with ctcae term, multi-organ failure
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 297 at risk

Adverse event: death not associated with ctcae term, sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 297 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 297 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 297 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 297 at risk

Adverse event: constitutional symptoms - other
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 297 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 297 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 297 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 297 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 297 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 297 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 297 at risk

Adverse event: gi - other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 297 at risk

Adverse event: perforation, gi, colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 297 at risk

Adverse event: stricture, gi, biliary tree
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 297 at risk

Adverse event: ulcer, gi, stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 297 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 297 at risk

Adverse event: cns hemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 297 at risk

Adverse event: hemorrhage, gi, abdomen nos
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 297 at risk

Adverse event: hemorrhage, gi, colon
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 297 at risk

Adverse event: hemorrhage, gi, duodenum
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 297 at risk

Adverse event: hemorrhage, gi, esophagus
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 297 at risk

Adverse event: hemorrhage, gi, varices (esophageal)
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 297 at risk

Adverse event: hemorrhage, gi, stomach
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 297 at risk

Adverse event: hemorrhage, gi, liver
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 297 at risk

Adverse event: hemorrhage, gi, peritoneal cavity
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 297 at risk

Adverse event: hemorrhage, gi, varices (rectal)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 297 at risk

Adverse event: hemorrhage, gi, upper gi nos
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 297 at risk

Adverse event: hemorrhage - other
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 297 at risk

Adverse event: hemorrhage pulmonary, lung
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 297 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 297 at risk

Adverse event: liver dysfunction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 297 at risk

Adverse event: hepatobiliary - other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 297 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 297 at risk

Adverse event: infection (documented clinically), abdomen nos
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 297 at risk

Adverse event: infection (documented clinically), anal/perianal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 297 at risk

Adverse event: infection (documented clinically), lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 297 at risk

Adverse event: infection (documented clinically), skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 297 at risk

Adverse event: infection (documented clinically), upper airway nos
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 297 at risk

Adverse event: infection (documented clinically), urinary tract nos
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 297 at risk

Adverse event: infection with normal anc, gallbladder (cholecystitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 297 at risk

Adverse event: infection - other
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 297 at risk

Adverse event: infection with unknown anc, biliary tree
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 297 at risk

Adverse event: infection with unknown anc, peritoneal cavity
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 297 at risk

Adverse event: infection with unknown anc, wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 297 at risk

Adverse event: edema: limb
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 297 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 297 at risk

Adverse event: musculoskeletal - other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 297 at risk

Adverse event: Aspartate aminotransferase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 297 at risk

Adverse event: Blood creatine phosphokinase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 297 at risk

Adverse event: bilirubin (hyperbilirubinemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 297 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 297 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 297 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 297 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 297 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 297 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 297 at risk

Adverse event: cns ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 297 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 297 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 297 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 297 at risk

Adverse event: mood alteration, depression
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 297 at risk

Adverse event: neuropathy: motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 297 at risk

Adverse event: neuropathy: sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 297 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 297 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 297 at risk

Adverse event: syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 297 at risk

Adverse event: pain, back
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 297 at risk

Adverse event: pain, extremity-limb
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 297 at risk

Adverse event: pain, tumor pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 297 at risk

Adverse event: pain, abdomen nos
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 297 at risk

Adverse event: pain, joint
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 297 at risk

Adverse event: pain, bone
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 297 at risk

Adverse event: pain, other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 297 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 297 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 297 at risk

Adverse event: dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 297 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 297 at risk

Adverse event: hand-foot skin reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 297 at risk

Adverse event: dermatology - other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 297 at risk

Adverse event: intraop injury, biliary tree - common bile duct
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 297 at risk

Adverse event: syndromes - other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 297 at risk

Adverse event: thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 297 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 297 at risk

Adverse event: conduction abnormality, asystole
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 297 at risk

Adverse event: cardiac arrhythmia - other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 297 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 297 at risk

Adverse event: obstruction, gi, small bowel nos
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 297 at risk

Adverse event: hemorrhage, gi, rectum
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 297 at risk

Adverse event: infection (documented clinically), blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 297 at risk

Adverse event: infection with normal anc, anal/perianal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 297 at risk

Adverse event: infection with normal anc, appendix
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 297 at risk

Adverse event: infection with normal anc, pancreas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 297 at risk

Adverse event: infection with unknown anc, appendix
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 297 at risk

Adverse event: infection with unknown anc, bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 297 at risk

Adverse event: lymphedema-related fibrosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 297 at risk

Adverse event: edema: head and neck
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 297 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 297 at risk

Adverse event: wound complication, non-infectious
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 297 at risk

Adverse event: Tumour flare
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 297 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 36 affected / 297 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 32 affected / 297 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 35 affected / 297 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 26 affected / 297 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 145 affected / 297 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 93 affected / 297 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 89 affected / 297 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 80 affected / 297 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 44 affected / 297 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 166 affected / 297 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 297 at risk

Adverse event: mucositis (functional/symptomatic), oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 297 at risk

Adverse event: mucositis (clinical exam), oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 297 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 73 affected / 297 at risk

Adverse event: gi - other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 297 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 297 at risk

Adverse event: liver dysfunction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 297 at risk

Adverse event: edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 59 affected / 297 at risk

Adverse event: musculoskeletal - other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 31 affected / 297 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 297 at risk

Adverse event: bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 28 affected / 297 at risk

Adverse event: pain, back
Serious: no
Organ System: General disorders
Frequency: 47 affected / 297 at risk

Adverse event: pain, abdomen nos
Serious: no
Organ System: General disorders
Frequency: 99 affected / 297 at risk

Adverse event: pain, head/headache
Serious: no
Organ System: General disorders
Frequency: 29 affected / 297 at risk

Adverse event: pain, joint
Serious: no
Organ System: General disorders
Frequency: 20 affected / 297 at risk

Adverse event: pain, stomach
Serious: no
Organ System: General disorders
Frequency: 23 affected / 297 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 297 at risk

Adverse event: dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 33 affected / 297 at risk

Adverse event: voice changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 27 affected / 297 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 46 affected / 297 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 31 affected / 297 at risk

Adverse event: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 67 affected / 297 at risk

Adverse event: dermatology - other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 30 affected / 297 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 44 affected / 297 at risk

Adverse event: rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 59 affected / 297 at risk

Adverse event: platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 297 at risk

Adverse event: constitutional symptoms - other
Serious: no
Organ System: General disorders
Frequency: 12 affected / 297 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 297 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 297 at risk

Adverse event: hepatobiliary - other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 297 at risk

Adverse event: infection - other
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 297 at risk

Adverse event: mood alteration, depression
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 297 at risk

Adverse event: pain, bone
Serious: no
Organ System: General disorders
Frequency: 16 affected / 297 at risk

Adverse event: pain, liver
Serious: no
Organ System: General disorders
Frequency: 13 affected / 297 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 297 at risk

Adverse event: flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 9 affected / 297 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 302 at risk

Adverse event: supraventricular arrhythmia, atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 302 at risk

Adverse event: conduction abnormality, av block - first degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 302 at risk

Adverse event: ventricular arrhythmia, ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 302 at risk

Adverse event: ventricular arrhythmia, ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 302 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 302 at risk

Adverse event: cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 302 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 302 at risk

Adverse event: cardiac general - other
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 302 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 302 at risk

Adverse event: death not associated with ctcae term, death nos
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 302 at risk

Adverse event: death not associated with ctcae term, disease progression nos
Serious: yes
Organ System: General disorders
Frequency: 66 affected / 302 at risk

Adverse event: death not associated with ctcae term, sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 302 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 302 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 302 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 302 at risk

Adverse event: constitutional symptoms - other
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 302 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 302 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 302 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 302 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 302 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 302 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 302 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 302 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 302 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 302 at risk

Adverse event: stricture, gi, biliary tree
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 302 at risk

Adverse event: ulcer, gi, duodenum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 302 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 302 at risk

Adverse event: cns hemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 302 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 302 at risk

Adverse event: hemorrhage, gi, abdomen nos
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 302 at risk

Adverse event: hemorrhage, gi, duodenum
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 302 at risk

Adverse event: hemorrhage, gi, esophagus
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 302 at risk

Adverse event: hemorrhage, gi, varices (esophageal)
Serious: yes
Organ System: Vascular disorders
Frequency: 13 affected / 302 at risk

Adverse event: hemorrhage, gi, stomach
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 302 at risk

Adverse event: hemorrhage, gi, liver
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 302 at risk

Adverse event: hemorrhage, gi, lower gi nos
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 302 at risk

Adverse event: hemorrhage, gi, oral cavity
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 302 at risk

Adverse event: hemorrhage, gi, peritoneal cavity
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 302 at risk

Adverse event: hemorrhage, gi, upper gi nos
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 302 at risk

Adverse event: hemorrhage with surgery
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 302 at risk

Adverse event: hemorrhage - other
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 302 at risk

Adverse event: hemorrhage pulmonary, pleura
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 302 at risk

Adverse event: liver dysfunction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 302 at risk

Adverse event: hepatobiliary - other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 302 at risk

Adverse event: infection (documented clinically), biliary tree
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 302 at risk

Adverse event: infection (documented clinically), lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 302 at risk

Adverse event: infection (documented clinically), skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 302 at risk

Adverse event: infection (documented clinically), soft tissue nos
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 302 at risk

Adverse event: infection with normal anc, bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 302 at risk

Adverse event: infection with normal anc, oral cavity-gums (gingivitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 302 at risk

Adverse event: infection with normal anc, peritoneal cavity
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 302 at risk

Adverse event: infection with normal anc, skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 302 at risk

Adverse event: infection with normal anc, urinary tract nos
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 302 at risk

Adverse event: infection - other
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 302 at risk

Adverse event: infection with unknown anc, lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 302 at risk

Adverse event: infection with unknown anc, peritoneal cavity
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 302 at risk

Adverse event: infection with unknown anc, urinary tract nos
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 302 at risk

Adverse event: lymphatics - other
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 302 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 302 at risk

Adverse event: musculoskeletal - other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 302 at risk

Adverse event: device/prosthesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 302 at risk

Adverse event: muscle weakness, whole body/generalized
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 302 at risk

Adverse event: Alanine aminotransferase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 302 at risk

Adverse event: Aspartate aminotransferase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 302 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 302 at risk

Adverse event: Gamma-glutamyltransferase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 302 at risk

Adverse event: bilirubin (hyperbilirubinemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 302 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 302 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 302 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 302 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 302 at risk

Adverse event: cns ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 302 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 302 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 302 at risk

Adverse event: neuropathy: motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 302 at risk

Adverse event: neurology - other
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 302 at risk

Adverse event: neuropathy: sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 302 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 302 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 302 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 302 at risk

Adverse event: pain, back
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 302 at risk

Adverse event: pain, tumor pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 302 at risk

Adverse event: pain, abdomen nos
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 302 at risk

Adverse event: pain, joint
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 302 at risk

Adverse event: pain, bone
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 302 at risk

Adverse event: pain, liver
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 302 at risk

Adverse event: pain, neuralgia/peripheral nerve
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 302 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 302 at risk

Adverse event: hiccoughs
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 302 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 302 at risk

Adverse event: pulmonary - other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 302 at risk

Adverse event: dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 302 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 302 at risk

Adverse event: obstruction, gu, ureter
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 302 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 302 at risk

Adverse event: thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 302 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 302 at risk

Adverse event: conduction abnormality, av block-3rd degree (complete av block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 302 at risk

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 302 at risk

Adverse event: distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 302 at risk

Adverse event: pain, chest/thorax nos
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 302 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 302 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 25 affected / 302 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 302 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 30 affected / 302 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 23 affected / 302 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 144 affected / 302 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 31 affected / 302 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 56 affected / 302 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 67 affected / 302 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 302 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 82 affected / 302 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 302 at risk

Adverse event: mucositis (functional/symptomatic), oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 302 at risk

Adverse event: mucositis (clinical exam), oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 302 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 63 affected / 302 at risk

Adverse event: gi - other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 302 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 302 at risk

Adverse event: liver dysfunction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 302 at risk

Adverse event: edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 57 affected / 302 at risk

Adverse event: musculoskeletal - other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 302 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 302 at risk

Adverse event: bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 26 affected / 302 at risk

Adverse event: pain, back
Serious: no
Organ System: General disorders
Frequency: 42 affected / 302 at risk

Adverse event: pain, abdomen nos
Serious: no
Organ System: General disorders
Frequency: 80 affected / 302 at risk

Adverse event: pain, head/headache
Serious: no
Organ System: General disorders
Frequency: 25 affected / 302 at risk

Adverse event: pain, joint
Serious: no
Organ System: General disorders
Frequency: 27 affected / 302 at risk

Adverse event: pain, stomach
Serious: no
Organ System: General disorders
Frequency: 21 affected / 302 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 302 at risk

Adverse event: dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 302 at risk

Adverse event: voice changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 302 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 302 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 302 at risk

Adverse event: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 302 at risk

Adverse event: dermatology - other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 302 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 302 at risk

Adverse event: rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 46 affected / 302 at risk

Adverse event: platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 302 at risk

Adverse event: constitutional symptoms - other
Serious: no
Organ System: General disorders
Frequency: 12 affected / 302 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 302 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 302 at risk

Adverse event: hepatobiliary - other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 302 at risk

Adverse event: infection - other
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 302 at risk

Adverse event: mood alteration, depression
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 302 at risk

Adverse event: pain, bone
Serious: no
Organ System: General disorders
Frequency: 15 affected / 302 at risk

Adverse event: pain, liver
Serious: no
Organ System: General disorders
Frequency: 16 affected / 302 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 302 at risk

Adverse event: flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 8 affected / 302 at risk

Adverse event: cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 47 at risk

Adverse event: death not associated with ctcae term, death nos
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: death not associated with ctcae term, disease progression nos
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 47 at risk

Adverse event: death not associated with ctcae term, sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: constitutional symptoms - other
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 47 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 47 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: gi - other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: ulcer, gi, duodenum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: hemorrhage, gi, esophagus
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 47 at risk

Adverse event: hemorrhage, gi, varices (esophageal)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 47 at risk

Adverse event: liver dysfunction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: hepatobiliary - other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 47 at risk

Adverse event: infection (documented clinically), lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 47 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 47 at risk

Adverse event: bilirubin (hyperbilirubinemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 47 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 47 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 47 at risk

Adverse event: cns ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 47 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 47 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 47 at risk

Adverse event: dermatology - other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 47 at risk

Adverse event: perforation, gi, appendix
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: hemorrhage, gi, rectum
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 47 at risk

Adverse event: infection with unknown anc, blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 47 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 47 at risk

Adverse event: Decubitus ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: Ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 47 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 47 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 47 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 47 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 23 affected / 47 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 10 affected / 47 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 47 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 47 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 47 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 47 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: mucositis (clinical exam), oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 47 at risk

Adverse event: gi - other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 47 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 47 at risk

Adverse event: liver dysfunction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 47 at risk

Adverse event: musculoskeletal - other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 47 at risk

Adverse event: bilirubin (hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 47 at risk

Adverse event: pain, back
Serious: no
Organ System: General disorders
Frequency: 4 affected / 47 at risk

Adverse event: pain, abdomen nos
Serious: no
Organ System: General disorders
Frequency: 11 affected / 47 at risk

Adverse event: pain, head/headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: pain, joint
Serious: no
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: pain, stomach
Serious: no
Organ System: General disorders
Frequency: 2 affected / 47 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 47 at risk

Adverse event: dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 47 at risk

Adverse event: voice changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 47 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 47 at risk

Adverse event: hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 47 at risk

Adverse event: dermatology - other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 47 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 47 at risk

Adverse event: rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 47 at risk

Adverse event: constitutional symptoms - other
Serious: no
Organ System: General disorders
Frequency: 4 affected / 47 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 47 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 47 at risk

Adverse event: hepatobiliary - other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 47 at risk

Adverse event: infection - other
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 47 at risk

Adverse event: mood alteration, depression
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 47 at risk

Adverse event: pain, liver
Serious: no
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 47 at risk

Adverse event: flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 3 affected / 47 at risk