Study: NCT01103323

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 500 at risk

Adverse event: Edema: Limb
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 500 at risk

Adverse event: International normalised ratio
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 500 at risk

Adverse event: Neutrophil count
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 500 at risk

Adverse event: Thrombotic microangiopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Cardiac arrhythmia - Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 500 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 500 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Supraventricular arrhythmia, Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 500 at risk

Adverse event: cTnT
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 500 at risk

Adverse event: Diplopia
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 500 at risk

Adverse event: Ocular - Other
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 500 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 500 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 500 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 500 at risk

Adverse event: Distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Fistula, GI, Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Fistula, GI, Anus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Fistula, GI, Small bowel NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: GI - Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 500 at risk

Adverse event: Mucositis (functional/symptomatic), Small bowel
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Necrosis, GI, Peritoneal cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Obstruction, GI, Colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 500 at risk

Adverse event: Obstruction, GI, Small bowel NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 500 at risk

Adverse event: Obstruction, GI, Stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Stricture, GI, Biliary tree
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Ulcer, GI, Duodenum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 500 at risk

Adverse event: Constitutional symptoms - Other
Serious: yes
Organ System: General disorders
Frequency: 34 affected / 500 at risk

Adverse event: Death not associated with CTCAE term, Disease progression NOS
Serious: yes
Organ System: General disorders
Frequency: 16 affected / 500 at risk

Adverse event: Death not associated with CTCAE term, Multi-Organ Failure
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 500 at risk

Adverse event: Death not associated with CTCAE term, Sudden death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 500 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 500 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 17 affected / 500 at risk

Adverse event: Pain, Abdomen NOS
Serious: yes
Organ System: General disorders
Frequency: 13 affected / 500 at risk

Adverse event: Pain, Back
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 500 at risk

Adverse event: Pain, Buttock
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 500 at risk

Adverse event: Pain, Chest wall
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 500 at risk

Adverse event: Pain, Chest/Thorax NOS
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 500 at risk

Adverse event: Pain, Extremity - limb
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 500 at risk

Adverse event: Pain, Head/Headache
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 500 at risk

Adverse event: Pain, Joint
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 500 at risk

Adverse event: Pain, Liver
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 500 at risk

Adverse event: Pain, Pain NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 500 at risk

Adverse event: Pain, Tumor pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 500 at risk

Adverse event: Syndromes - Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 500 at risk

Adverse event: Tumour flare
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 500 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 500 at risk

Adverse event: Hepatobiliary - Other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 500 at risk

Adverse event: Liver dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 17 affected / 500 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 500 at risk

Adverse event: Infection (documented clinically), Abdomen NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 500 at risk

Adverse event: Infection (documented clinically), Anal/perianal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Infection (documented clinically), Appendix
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Infection (documented clinically), Bladder (urinary)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 500 at risk

Adverse event: Infection (documented clinically), Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 500 at risk

Adverse event: Infection (documented clinically), Bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 500 at risk

Adverse event: Infection (documented clinically), Catheter-related
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Infection (documented clinically), Kidney
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Infection (documented clinically), Lung (Pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 500 at risk

Adverse event: Infection (documented clinically), Skin (Cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Infection (documented clinically), Soft tissue NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Infection (documented clinically), Urinary tract NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 500 at risk

Adverse event: Infection (documented clinically), Wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 500 at risk

Adverse event: Infection with normal ANC, Catheter-related
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Infection with normal ANC, Colon
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Infection with normal ANC, Gallbladder (Cholecystitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Infection with normal ANC, Kidney
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Infection with normal ANC, Lung (Pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Infection with normal ANC, Soft tissue NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 500 at risk

Adverse event: Infection with unknown ANC, Kidney
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Infection with unknown ANC, Lung (Pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 500 at risk

Adverse event: Bilirubin (Hyperbilirubinemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 500 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 500 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 500 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 500 at risk

Adverse event: Metabolic/Lab - Other
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 500 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 500 at risk

Adverse event: Gait/Walking
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 500 at risk

Adverse event: Muscle weakness, Extremity - lower
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 500 at risk

Adverse event: Musculoskeletal - Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 500 at risk

Adverse event: Myositis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 500 at risk

Adverse event: Secondary malignancy (possibly related to cancer treatment)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 500 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: CNS ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 500 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 500 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Mood Alteration, Anxiety
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Neurology - Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 500 at risk

Adverse event: Neuropathy: motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 500 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Speech impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 500 at risk

Adverse event: Syncope (Fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 500 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 500 at risk

Adverse event: Fistula, GU, Bladder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 500 at risk

Adverse event: Obstruction, GU, Ureter
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 500 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 500 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Dyspnea (Shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 500 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 500 at risk

Adverse event: Pulmonary - Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 500 at risk

Adverse event: Dermatology - Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 500 at risk

Adverse event: Erythema multiforme
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 500 at risk

Adverse event: Hand-foot skin reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 500 at risk

Adverse event: Rash/Desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 500 at risk

Adverse event: Hemorrhage - Other
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 500 at risk

Adverse event: Hemorrhage pulmonary, Bronchus
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 500 at risk

Adverse event: Hemorrhage pulmonary, Mediastinum
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 500 at risk

Adverse event: Hemorrhage, GI, Abdomen NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 500 at risk

Adverse event: Hemorrhage, GI, Anus
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 500 at risk

Adverse event: Hemorrhage, GI, Lower GI NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 500 at risk

Adverse event: Hemorrhage, GI, Rectum
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 500 at risk

Adverse event: Hemorrhage, GI, Stoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 500 at risk

Adverse event: Hemorrhage, GI, Upper GI NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 500 at risk

Adverse event: Hemorrhage, GI, Varices (rectal)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 500 at risk

Adverse event: Hemorrhage, GU, Vagina
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 500 at risk

Adverse event: Thrombosis/Thrombus/Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 500 at risk

Adverse event: Vascular - Other
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 500 at risk

Adverse event: Edema: Limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 49 affected / 500 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 76 affected / 500 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 79 affected / 500 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 155 affected / 500 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 27 affected / 500 at risk

Adverse event: Ocular - Other
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 500 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 239 affected / 500 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 500 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 119 affected / 500 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 218 affected / 500 at risk

Adverse event: Mucositis (functional/symptomatic), Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 145 affected / 500 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 115 affected / 500 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 39 affected / 500 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 85 affected / 500 at risk

Adverse event: Constitutional symptoms - Other
Serious: no
Organ System: General disorders
Frequency: 30 affected / 500 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 318 affected / 500 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 136 affected / 500 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 27 affected / 500 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 39 affected / 500 at risk

Adverse event: Pain, Abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 121 affected / 500 at risk

Adverse event: Pain, Back
Serious: no
Organ System: General disorders
Frequency: 79 affected / 500 at risk

Adverse event: Pain, Buttock
Serious: no
Organ System: General disorders
Frequency: 4 affected / 500 at risk

Adverse event: Pain, Chest/Thorax NOS
Serious: no
Organ System: General disorders
Frequency: 26 affected / 500 at risk

Adverse event: Pain, Extremity - limb
Serious: no
Organ System: General disorders
Frequency: 51 affected / 500 at risk

Adverse event: Pain, Head/Headache
Serious: no
Organ System: General disorders
Frequency: 50 affected / 500 at risk

Adverse event: Pain, Joint
Serious: no
Organ System: General disorders
Frequency: 32 affected / 500 at risk

Adverse event: Pain, Muscle
Serious: no
Organ System: General disorders
Frequency: 50 affected / 500 at risk

Adverse event: Pain, Throat/Pharynx/Larynx
Serious: no
Organ System: General disorders
Frequency: 9 affected / 500 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 167 affected / 500 at risk

Adverse event: Hepatobiliary - Other
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 500 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 28 affected / 500 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 37 affected / 500 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 35 affected / 500 at risk

Adverse event: Bilirubin (Hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 97 affected / 500 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 500 at risk

Adverse event: Glomerular filtration rate
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 500 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 500 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 34 affected / 500 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 50 affected / 500 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 32 affected / 500 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 32 affected / 500 at risk

Adverse event: Lipase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 32 affected / 500 at risk

Adverse event: Metabolic/Lab - Other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 42 affected / 500 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 40 affected / 500 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 500 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 51 affected / 500 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 56 affected / 500 at risk

Adverse event: Dyspnea (Shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 89 affected / 500 at risk

Adverse event: Voice changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 160 affected / 500 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 39 affected / 500 at risk

Adverse event: Cheilitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 500 at risk

Adverse event: Dermatology - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 30 affected / 500 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 50 affected / 500 at risk

Adverse event: Hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 235 affected / 500 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 500 at risk

Adverse event: Rash/Desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 145 affected / 500 at risk

Adverse event: Hemorrhage pulmonary, Nose
Serious: no
Organ System: Vascular disorders
Frequency: 45 affected / 500 at risk

Adverse event: Edema: Limb
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 253 at risk

Adverse event: Edema: Trunk/Genital
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 253 at risk

Adverse event: Edema: Viscera
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 253 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 253 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 253 at risk

Adverse event: Diplopia
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 253 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 253 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 253 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 253 at risk

Adverse event: Fistula, GI, Abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 253 at risk

Adverse event: GI - Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 253 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 253 at risk

Adverse event: Obstruction, GI, Colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 253 at risk

Adverse event: Obstruction, GI, Ileum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 253 at risk

Adverse event: Obstruction, GI, Small bowel NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 253 at risk

Adverse event: Perforation, GI, Colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 253 at risk

Adverse event: Constitutional symptoms - Other
Serious: yes
Organ System: General disorders
Frequency: 23 affected / 253 at risk

Adverse event: Death not associated with CTCAE term, Disease progression NOS
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 253 at risk

Adverse event: Death not associated with CTCAE term, Multi-Organ Failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 253 at risk

Adverse event: Death not associated with CTCAE term, Sudden death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 253 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 253 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 253 at risk

Adverse event: Pain, Abdomen NOS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 253 at risk

Adverse event: Pain, Back
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 253 at risk

Adverse event: Pain, Cardiac/Heart
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 253 at risk

Adverse event: Pain, Chest/Thorax NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 253 at risk

Adverse event: Pain, Head/Headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 253 at risk

Adverse event: Pain, Neuralgia/Peripheral nerve
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 253 at risk

Adverse event: Pain, Tumor pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 253 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 253 at risk

Adverse event: Hepatobiliary - Other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 253 at risk

Adverse event: Liver dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 253 at risk

Adverse event: Infection (documented clinically), Bladder (urinary)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 253 at risk

Adverse event: Infection (documented clinically), Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 253 at risk

Adverse event: Infection (documented clinically), Kidney
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 253 at risk

Adverse event: Infection (documented clinically), Lung (Pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 253 at risk

Adverse event: Infection - Other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 253 at risk

Adverse event: Infection with normal ANC, Blood
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 253 at risk

Adverse event: Infection with normal ANC, Lung (Pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 253 at risk

Adverse event: Infection with unknown ANC, Lung (Pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 253 at risk

Adverse event: Aspartate aminotransferase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 253 at risk

Adverse event: Bilirubin (Hyperbilirubinemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 253 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 253 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 253 at risk

Adverse event: Muscle weakness, Whole body/generalized
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 253 at risk

Adverse event: CNS ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 253 at risk

Adverse event: Neurology - Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 253 at risk

Adverse event: Neuropathy: Cranial, CN III Pupil, upper eyelid, extra ocular mov
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 253 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 253 at risk

Adverse event: Obstruction, GU, Ureter
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 253 at risk

Adverse event: Renal - Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 253 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 253 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 253 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 253 at risk

Adverse event: Dyspnea (Shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 253 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 253 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 253 at risk

Adverse event: Dermatology - Other
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 253 at risk

Adverse event: Rash/Desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 253 at risk

Adverse event: Wound complication, non-infectious
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 253 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 253 at risk

Adverse event: Hemorrhage, GI, Varices (esophageal)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 253 at risk

Adverse event: Thrombosis/Embolism (vascular access)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 253 at risk

Adverse event: Thrombosis/Thrombus/Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 253 at risk

Adverse event: Edema: Limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 253 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 29 affected / 253 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 253 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 21 affected / 253 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 253 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 73 affected / 253 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 253 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 253 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 44 affected / 253 at risk

Adverse event: Mucositis (functional/symptomatic), Oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 253 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 55 affected / 253 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 253 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 253 at risk

Adverse event: Constitutional symptoms - Other
Serious: no
Organ System: General disorders
Frequency: 17 affected / 253 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 115 affected / 253 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 40 affected / 253 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 6 affected / 253 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 14 affected / 253 at risk

Adverse event: Pain, Abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 47 affected / 253 at risk

Adverse event: Pain, Back
Serious: no
Organ System: General disorders
Frequency: 25 affected / 253 at risk

Adverse event: Pain, Chest/Thorax NOS
Serious: no
Organ System: General disorders
Frequency: 12 affected / 253 at risk

Adverse event: Pain, Extremity - limb
Serious: no
Organ System: General disorders
Frequency: 14 affected / 253 at risk

Adverse event: Pain, Head/Headache
Serious: no
Organ System: General disorders
Frequency: 18 affected / 253 at risk

Adverse event: Pain, Joint
Serious: no
Organ System: General disorders
Frequency: 13 affected / 253 at risk

Adverse event: Pain, Muscle
Serious: no
Organ System: General disorders
Frequency: 14 affected / 253 at risk

Adverse event: Pain, Throat/Pharynx/Larynx
Serious: no
Organ System: General disorders
Frequency: 1 affected / 253 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 30 affected / 253 at risk

Adverse event: Hepatobiliary - Other
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 253 at risk

Adverse event: Alanine aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 253 at risk

Adverse event: Aspartate aminotransferase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 253 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 253 at risk

Adverse event: Bilirubin (Hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 253 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 253 at risk

Adverse event: Glomerular filtration rate
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 253 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 253 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 253 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 253 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 253 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 253 at risk

Adverse event: Lipase
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 253 at risk

Adverse event: Metabolic/Lab - Other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 253 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 253 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 253 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 253 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 253 at risk

Adverse event: Dyspnea (Shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 34 affected / 253 at risk

Adverse event: Voice changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 253 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 253 at risk

Adverse event: Dermatology - Other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 253 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 253 at risk

Adverse event: Hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 253 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 253 at risk

Adverse event: Rash/Desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 253 at risk

Adverse event: Hemorrhage pulmonary, Nose
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 253 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Death not associated with CTCAE term, Disease progression NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 4 at risk

Adverse event: Ocular - Other
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 4 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4 at risk

Adverse event: Fistula, GI, Colon/Cecum/Appendix
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 4 at risk

Adverse event: Flu-like syndrome
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pain, Buttock
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Pain, Throat/Pharynx/Larynx
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 2 affected / 4 at risk

Adverse event: Hepatobiliary - Other
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4 at risk

Adverse event: Bilirubin (Hyperbilirubinemia)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: Blood creatinine
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: Glomerular filtration rate
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Voice changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Cheilitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: Rash/Desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4 at risk