Study: NCT00300885

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 11 affected / 463 at risk

Adverse event: Neutrophil count
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 463 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 463 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 463 at risk

Adverse event: Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 463 at risk

Adverse event: Leukocytes
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 463 at risk

Adverse event: Supraventricular arrhythmia, atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 463 at risk

Adverse event: Conduction abnormality, asystole
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 463 at risk

Adverse event: Supraventricular arrhythmia, sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 463 at risk

Adverse event: Supraventricular arrhythmia, supravent extrasystoles (pac;premnodal/junct contr)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 463 at risk

Adverse event: Supraventricular arrhythmia, supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 463 at risk

Adverse event: Supraventricular arrhythmia, sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 463 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 463 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 463 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 463 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 463 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 463 at risk

Adverse event: Death not associated with CTCAE term, death NOS
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 463 at risk

Adverse event: Death not associated with CTCAE term, disease progression NOS
Serious: yes
Organ System: General disorders
Frequency: 23 affected / 463 at risk

Adverse event: Death not associated with CTCAE term, sudden death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 463 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 463 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 17 affected / 463 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 463 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 463 at risk

Adverse event: Constitutional symptoms - other
Serious: yes
Organ System: General disorders
Frequency: 19 affected / 463 at risk

Adverse event: Rigors/chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 463 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 463 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 463 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 463 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 463 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Mucositis (clinical exam), oral cavity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Necrosis, GI, anus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 463 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 463 at risk

Adverse event: Perforation, GI, colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 463 at risk

Adverse event: Hemorrhage, GI, abdomen NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 463 at risk

Adverse event: Hemorrhage, GI, duodenum
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 463 at risk

Adverse event: Hemorrhage, GI, lower GI NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 463 at risk

Adverse event: Hemorrhage pulmonary, lung
Serious: yes
Organ System: Vascular disorders
Frequency: 11 affected / 463 at risk

Adverse event: Hemorrhage pulmonary, nose
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 463 at risk

Adverse event: Hemorrhage pulmonary, respiratory tract NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 463 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 463 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 463 at risk

Adverse event: Infection (documented clinically), abdomen NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 463 at risk

Adverse event: Infection (documented clinically), blood
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 463 at risk

Adverse event: Infection (documented clinically), bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 463 at risk

Adverse event: Infection (documented clinically), lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 25 affected / 463 at risk

Adverse event: Infection (documented clinically), skin (cellulitis)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 463 at risk

Adverse event: Infection (documented clinically), upper airway NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 463 at risk

Adverse event: Infection (documented clinically), urinary tract NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 463 at risk

Adverse event: Infection with normal ANC, blood
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 463 at risk

Adverse event: Infection with normal ANC, bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 463 at risk

Adverse event: Infection with normal ANC, catheter-related
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 463 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 16 affected / 463 at risk

Adverse event: Infection with normal ANC, lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 463 at risk

Adverse event: Infection with normal ANC, upper airway NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 463 at risk

Adverse event: Infection - other
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 463 at risk

Adverse event: Infection with unknown ANC, lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 463 at risk

Adverse event: Edema: limb
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 463 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 463 at risk

Adverse event: Muscuskeletal - other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 463 at risk

Adverse event: Muscle weakness, whole body/generalized
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 463 at risk

Adverse event: Blood alkaline phosphatase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 463 at risk

Adverse event: Alanine aminotransferase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 463 at risk

Adverse event: Aspartate aminotransferase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 463 at risk

Adverse event: Blood creatinine
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 463 at risk

Adverse event: Gamma-glutamyltransferase
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 463 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 463 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 463 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 463 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 463 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 463 at risk

Adverse event: Mood alteration, agitation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 463 at risk

Adverse event: CNS ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 463 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 463 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 463 at risk

Adverse event: Speech impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 463 at risk

Adverse event: Mood alteration, depression
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 463 at risk

Adverse event: Neuropathy: motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 463 at risk

Adverse event: Neurology - other
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 463 at risk

Adverse event: Neuropathy: sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 463 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 463 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 463 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 463 at risk

Adverse event: Pain, back
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 463 at risk

Adverse event: Pain, chest wall
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 463 at risk

Adverse event: Pain, tumor pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 463 at risk

Adverse event: Pain, abdomen NOS
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 463 at risk

Adverse event: Pain, joint
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 463 at risk

Adverse event: Pain, bone
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 463 at risk

Adverse event: Pain, liver
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 463 at risk

Adverse event: Pain, pain NOS
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 463 at risk

Adverse event: Pain, stomach
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 463 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 463 at risk

Adverse event: Fistula, pulmonary, lung
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 463 at risk

Adverse event: Pulmonary - other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 463 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 463 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 463 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 463 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 463 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 463 at risk

Adverse event: Hand-foot skin reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 463 at risk

Adverse event: Rash/desquamation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 463 at risk

Adverse event: Intraop injury, bone
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 463 at risk

Adverse event: Syndromes - other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 463 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 16 affected / 463 at risk

Adverse event: Bone marrow cellularity
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 463 at risk

Adverse event: Supraventricular arrhythmia, atrial
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 463 at risk

Adverse event: cardiac general - other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 463 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: perforation, GI, stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Hemorrhage, Gu, bladder
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 463 at risk

Adverse event: Infection (documented clinically), anal/perianal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 463 at risk

Adverse event: Infection (documented clinically), mucosa
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 463 at risk

Adverse event: Infection with normal ANC, anal/perianal
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 463 at risk

Adverse event: Infection with normal ANC, pleura (empyema)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 463 at risk

Adverse event: Infection with normal ANC, urethra
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 463 at risk

Adverse event: Opportunistic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 463 at risk

Adverse event: Infection with unknown ANC, muscle (infection myositis)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 463 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 463 at risk

Adverse event: Pain, neck
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 463 at risk

Adverse event: Flushing
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 463 at risk

Adverse event: Intraop injury, lung
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 463 at risk

Adverse event: Flu-like syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 463 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 170 affected / 463 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 145 affected / 463 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 140 affected / 463 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 78 affected / 463 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 90 affected / 463 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 85 affected / 463 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 79 affected / 463 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 251 affected / 463 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 99 affected / 463 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 149 affected / 463 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 126 affected / 463 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 205 affected / 463 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 47 affected / 463 at risk

Adverse event: Mucositis (clinical exam), oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 77 affected / 463 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 201 affected / 463 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 122 affected / 463 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 52 affected / 463 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 55 affected / 463 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 236 affected / 463 at risk

Adverse event: Pain, back
Serious: no
Organ System: General disorders
Frequency: 50 affected / 463 at risk

Adverse event: Pain, chest/thorax NOS
Serious: no
Organ System: General disorders
Frequency: 70 affected / 463 at risk

Adverse event: Pain, extremity-limb
Serious: no
Organ System: General disorders
Frequency: 69 affected / 463 at risk

Adverse event: Pain, abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 60 affected / 463 at risk

Adverse event: Pain, head/headache
Serious: no
Organ System: General disorders
Frequency: 52 affected / 463 at risk

Adverse event: Pain, joint
Serious: no
Organ System: General disorders
Frequency: 83 affected / 463 at risk

Adverse event: Pain, muscle
Serious: no
Organ System: General disorders
Frequency: 96 affected / 463 at risk

Adverse event: Pain, bone
Serious: no
Organ System: General disorders
Frequency: 52 affected / 463 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 142 affected / 463 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 138 affected / 463 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 214 affected / 463 at risk

Adverse event: Hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 113 affected / 463 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 66 affected / 463 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 239 affected / 463 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 29 affected / 463 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 36 affected / 463 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 30 affected / 463 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 463 at risk

Adverse event: Mucositis (functional/symptomatic), oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 463 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 43 affected / 463 at risk

Adverse event: Hemorrhage pulmonary, nose
Serious: no
Organ System: Vascular disorders
Frequency: 46 affected / 463 at risk

Adverse event: Pain, throat / pharynx / larynx
Serious: no
Organ System: General disorders
Frequency: 24 affected / 463 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 46 affected / 463 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 40 affected / 463 at risk

Adverse event: Mood alteration, anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 42 affected / 463 at risk

Adverse event: Mood alteration, depression
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 463 at risk

Adverse event: Voice changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 463 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 41 affected / 463 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 25 affected / 463 at risk

Adverse event: Pain, tumor pain
Serious: no
Organ System: General disorders
Frequency: 22 affected / 463 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Immune system disorders
Frequency: 18 affected / 463 at risk

Adverse event: Muscle weakness, whole body / generalized
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 27 affected / 463 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 463 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 4 affected / 459 at risk

Adverse event: Neutrophil count
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 459 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 459 at risk

Adverse event: Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 459 at risk

Adverse event: Leukocytes
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 459 at risk

Adverse event: Supraventricular arrhythmia, atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 459 at risk

Adverse event: vasovagal episode
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 459 at risk

Adverse event: Ventricular arrhythmia, ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 459 at risk

Adverse event: Ventricular arrhythmia, ventricular arrhythmia NOS
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 459 at risk

Adverse event: Ventricular arrhythmia, ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 459 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 459 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 459 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 459 at risk

Adverse event: Cardiac ischemia/infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 459 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 459 at risk

Adverse event: Death not associated with CTCAE term, death NOS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 459 at risk

Adverse event: Death not associated with CTCAE term, disease progression NOS
Serious: yes
Organ System: General disorders
Frequency: 24 affected / 459 at risk

Adverse event: Death not associated with CTCAE term, multi-organ failure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 459 at risk

Adverse event: Death not associated with CTCAE term, sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 459 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 459 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 459 at risk

Adverse event: Constitutional symptoms - other
Serious: yes
Organ System: General disorders
Frequency: 13 affected / 459 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 459 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 459 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 459 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 459 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 459 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 459 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 459 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 459 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 459 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 459 at risk

Adverse event: Ulcer, GI, stomach
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 459 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 459 at risk

Adverse event: Hemorrhage, GI, colon
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 459 at risk

Adverse event: Hemorrhage, GI, stomach
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 459 at risk

Adverse event: Hemorrhage, GI, upper GI, NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 459 at risk

Adverse event: Hemorrhage pulmonary, bronchopulmonary NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 459 at risk

Adverse event: Hemorrhage pulmonary, bronchus
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 459 at risk

Adverse event: Hemorrhage pulmonary, lung
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 459 at risk

Adverse event: Hemorrhage pulmonary, respiratory tract NOS
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 459 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 459 at risk

Adverse event: Hepatobilary - other
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 459 at risk

Adverse event: Infection (documented clinically), bladder (urinary)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 459 at risk

Adverse event: Infection (documented clinically), bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 459 at risk

Adverse event: Infection (documented clinically), lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 459 at risk

Adverse event: Infection (documented clinically), pleura (empyema)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 459 at risk

Adverse event: Infection (documented clinically), upper airway NOS
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 459 at risk

Adverse event: Infection (documented clinically), vein
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 459 at risk

Adverse event: Infection with normal ANC, blood
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 459 at risk

Adverse event: Infection with normal ANC, bronchus
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 459 at risk

Adverse event: Infection with normal ANC, colon
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 459 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 459 at risk

Adverse event: Infection with normal ANC, lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 459 at risk

Adverse event: Infection - other
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 459 at risk

Adverse event: Infection with unknown ANC, anal/perianal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 459 at risk

Adverse event: Infection with unknown ANC, lung (pneumonia)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 459 at risk

Adverse event: Infection with unknown ANC, pleura (empyema)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 459 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 459 at risk

Adverse event: Muscuskeletal - other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 459 at risk

Adverse event: Muscle weakness, extremity-lower
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 459 at risk

Adverse event: Muscle weakness, whole body/generalized
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 459 at risk

Adverse event: Bilirubin (hyperbilirubinemia)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 459 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 459 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 459 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 459 at risk

Adverse event: CNS ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 459 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 459 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 459 at risk

Adverse event: Mood alteration, euphoria
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 459 at risk

Adverse event: Neuropathy: motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 459 at risk

Adverse event: Neurology - other
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 459 at risk

Adverse event: Neuropathy: sensory
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 459 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 459 at risk

Adverse event: Syncope (fainting)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 459 at risk

Adverse event: Pain, back
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 459 at risk

Adverse event: Pain, chest/thorax NOS
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 459 at risk

Adverse event: Pain, chest wall
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 459 at risk

Adverse event: Pain, tumor pain
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 459 at risk

Adverse event: Pain, abdomen NOS
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 459 at risk

Adverse event: Pain, muscle
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 459 at risk

Adverse event: Pain, bone
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 459 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 459 at risk

Adverse event: Fistula, pulmonary, bronchus
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 459 at risk

Adverse event: Airway obstruction, bronchus
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 459 at risk

Adverse event: Pulmonary - other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 459 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 459 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 459 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 459 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 459 at risk

Adverse event: Thrombosis/embolism (vascular access)
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 459 at risk

Adverse event: Vascular - other
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 459 at risk

Adverse event: Thrombosis/thrombus/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 17 affected / 459 at risk

Adverse event: Bone marrow cellularity
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 459 at risk

Adverse event: cardiac general - other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 459 at risk

Adverse event: Fistula, GI, abdomen NOS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 459 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 459 at risk

Adverse event: Hemorrhage, GI, esophagus
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 459 at risk

Adverse event: Infection with unknown ANC, blood
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 459 at risk

Adverse event: Contusion
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 459 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 459 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 168 affected / 459 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 148 affected / 459 at risk

Adverse event: Platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 67 affected / 459 at risk

Adverse event: Leukocytes
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 67 affected / 459 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 46 affected / 459 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 60 affected / 459 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 83 affected / 459 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 228 affected / 459 at risk

Adverse event: Weight decreased
Serious: no
Organ System: General disorders
Frequency: 57 affected / 459 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 122 affected / 459 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 107 affected / 459 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 107 affected / 459 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 459 at risk

Adverse event: Mucositis (clinical exam), oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 459 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 204 affected / 459 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 108 affected / 459 at risk

Adverse event: Edema: limb
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 51 affected / 459 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 52 affected / 459 at risk

Adverse event: Neuropathy: sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 250 affected / 459 at risk

Adverse event: Pain, back
Serious: no
Organ System: General disorders
Frequency: 53 affected / 459 at risk

Adverse event: Pain, chest/thorax NOS
Serious: no
Organ System: General disorders
Frequency: 70 affected / 459 at risk

Adverse event: Pain, extremity-limb
Serious: no
Organ System: General disorders
Frequency: 58 affected / 459 at risk

Adverse event: Pain, abdomen NOS
Serious: no
Organ System: General disorders
Frequency: 50 affected / 459 at risk

Adverse event: Pain, head/headache
Serious: no
Organ System: General disorders
Frequency: 50 affected / 459 at risk

Adverse event: Pain, joint
Serious: no
Organ System: General disorders
Frequency: 100 affected / 459 at risk

Adverse event: Pain, muscle
Serious: no
Organ System: General disorders
Frequency: 120 affected / 459 at risk

Adverse event: Pain, bone
Serious: no
Organ System: General disorders
Frequency: 41 affected / 459 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 138 affected / 459 at risk

Adverse event: Dyspnea (shortness of breath)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 136 affected / 459 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 215 affected / 459 at risk

Adverse event: Hand-foot skin reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 459 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 459 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 80 affected / 459 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 30 affected / 459 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 28 affected / 459 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 31 affected / 459 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 459 at risk

Adverse event: Mucositis (functional/symptomatic), oral cavity
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 459 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 459 at risk

Adverse event: Hemorrhage pulmonary, nose
Serious: no
Organ System: Vascular disorders
Frequency: 21 affected / 459 at risk

Adverse event: Pain, throat / pharynx / larynx
Serious: no
Organ System: General disorders
Frequency: 17 affected / 459 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 459 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 26 affected / 459 at risk

Adverse event: Mood alteration, anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 35 affected / 459 at risk

Adverse event: Mood alteration, depression
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 459 at risk

Adverse event: Voice changes
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 459 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 459 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 459 at risk

Adverse event: Pain, tumor pain
Serious: no
Organ System: General disorders
Frequency: 23 affected / 459 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Immune system disorders
Frequency: 23 affected / 459 at risk

Adverse event: Muscle weakness, whole body / generalized
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 459 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 459 at risk