Study: NCT00436618

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 114 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 114 at risk

Adverse event: Cardiac disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 114 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 114 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 114 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Intra-abdominal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 114 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 114 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 114 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 114 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 114 at risk

Adverse event: Biliary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Colitis, infectious (e.g., Clostridium difficile)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Gingivitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 114 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 114 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 114 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 114 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 114 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 114 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 114 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 15 affected / 114 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 114 at risk

Adverse event: Blood potassium decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 114 at risk

Adverse event: Blood sodium decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 114 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 114 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 114 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 114 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 114 at risk

Adverse event: Urethral obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 114 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 114 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 114 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 114 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 107 affected / 114 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 114 at risk

Adverse event: Cardiac disorder
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 114 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 114 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 114 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 114 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 114 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 114 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 114 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Ear, nose and throat examination abnormal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 114 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 114 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 114 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 114 at risk

Adverse event: Disease progression
Serious: no
Organ System: General disorders
Frequency: 1 affected / 114 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 4 affected / 114 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 34 affected / 114 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 114 at risk

Adverse event: General symptom
Serious: no
Organ System: General disorders
Frequency: 1 affected / 114 at risk

Adverse event: Ill-defined disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 114 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 114 at risk

Adverse event: Visceral oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 114 at risk

Adverse event: Anal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 114 at risk

Adverse event: Device related infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Gastric infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 114 at risk

Adverse event: Lip infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Pleural infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 114 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 114 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 114 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 114 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 114 at risk

Adverse event: Hepatitis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 114 at risk

Adverse event: Recall phenomenon
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 114 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 114 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 114 at risk

Adverse event: Troponin I increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 114 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 114 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 70 affected / 114 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 62 affected / 114 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 91 affected / 114 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 114 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 114 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 114 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 114 at risk

Adverse event: Blood uric acid increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 114 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 114 at risk

Adverse event: Glucose tolerance impaired
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 114 at risk

Adverse event: Blood potassium increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 114 at risk

Adverse event: Blood sodium decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 114 at risk

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 114 at risk

Adverse event: Tumour lysis syndrome
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 114 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 114 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 114 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 114 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 114 at risk

Adverse event: Accessory nerve disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 114 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 114 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 114 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 114 at risk

Adverse event: Mini mental status examination abnormal
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 114 at risk

Adverse event: Peripheral motor neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 114 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 114 at risk

Adverse event: Speech disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 114 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 114 at risk

Adverse event: Trigeminal nerve disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 114 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 114 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 114 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 114 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 114 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Laryngoscopy abnormal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Pharyngeal stenosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 114 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 114 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 114 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 114 at risk

Adverse event: Exfoliative rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 114 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 114 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 55 at risk

Adverse event: Opportunistic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 55 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 55 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 55 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 55 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 55 at risk

Adverse event: Speech disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 55 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 55 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 49 affected / 55 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 55 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 55 at risk

Adverse event: Ear, nose and throat examination abnormal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 55 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 55 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Proctoscopy abnormal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 55 at risk

Adverse event: Disease progression
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 21 affected / 55 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 55 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 55 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 55 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 55 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 55 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 55 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 55 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 55 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 55 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 55 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 55 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 25 affected / 55 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 25 affected / 55 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 40 affected / 55 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 55 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 55 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 55 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 55 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 55 at risk

Adverse event: Blood potassium decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 55 at risk

Adverse event: Blood sodium decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 55 at risk

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 55 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 55 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 55 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 55 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 55 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 55 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 55 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 55 at risk

Adverse event: Acute respiratory distress syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 55 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 55 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 55 at risk

Adverse event: Pleuritic pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 55 at risk

Adverse event: Pulmonary haemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Exfoliative rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 55 at risk

Adverse event: Skin disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 55 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 55 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 55 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 107 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 107 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 107 at risk

Adverse event: Restrictive cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 107 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 107 at risk

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 107 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 107 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 107 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 107 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 107 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 107 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 107 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 107 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 107 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 12 affected / 107 at risk

Adverse event: Blood glucose increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 107 at risk

Adverse event: Blood calcium decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 107 at risk

Adverse event: Blood sodium decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 107 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 107 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 107 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 107 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 103 affected / 107 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 107 at risk

Adverse event: Left ventricular failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 107 at risk

Adverse event: Myocardial ischaemia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 107 at risk

Adverse event: Myocarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 107 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 107 at risk

Adverse event: Restrictive cardiomyopathy
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 107 at risk

Adverse event: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 107 at risk

Adverse event: Hypoacusis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 107 at risk

Adverse event: Adrenal insufficiency
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 107 at risk

Adverse event: Eye disorder
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 107 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 107 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 107 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 107 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 107 at risk

Adverse event: Ear, nose and throat examination abnormal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 107 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 107 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 107 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 107 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 107 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 107 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 107 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 4 affected / 107 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 32 affected / 107 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 107 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 107 at risk

Adverse event: Gallbladder obstruction
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 107 at risk

Adverse event: Abdominal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 107 at risk

Adverse event: Anal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 107 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 107 at risk

Adverse event: Large intestine infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 107 at risk

Adverse event: Colitis, infectious (e.g., Clostridium difficile)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 107 at risk

Adverse event: Gastric infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 107 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 107 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 107 at risk

Adverse event: Lip infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 107 at risk

Adverse event: Mucosal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 107 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 107 at risk

Adverse event: Penile infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 107 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 107 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 107 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 107 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 107 at risk

Adverse event: Upper aerodigestive tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 107 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 107 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 107 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 107 at risk

Adverse event: Vascular access complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 107 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 107 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 107 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 107 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 107 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 67 affected / 107 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 51 affected / 107 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 74 affected / 107 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 107 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 107 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 107 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 107 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 107 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 107 at risk

Adverse event: Blood calcium decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 107 at risk

Adverse event: Blood glucose decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 107 at risk

Adverse event: Blood potassium decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 107 at risk

Adverse event: Blood potassium increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 107 at risk

Adverse event: Blood sodium decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 107 at risk

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 107 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 107 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 107 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 107 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 107 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 107 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 107 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 107 at risk

Adverse event: Second primary malignancy
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 107 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 107 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 107 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 107 at risk

Adverse event: Cerebral ischaemia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 107 at risk

Adverse event: Nervous system disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 107 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 107 at risk

Adverse event: Radiculitis brachial
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 107 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 107 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 107 at risk

Adverse event: Ureteric stenosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 107 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 107 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 107 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 107 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 107 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 107 at risk

Adverse event: Laryngeal inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 107 at risk

Adverse event: Ear, nose and throat examination abnormal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 107 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 107 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 107 at risk

Adverse event: Pulmonary fibrosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 107 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 107 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 107 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 107 at risk

Adverse event: Dermatitis acneiform
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 107 at risk

Adverse event: Exfoliative rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 107 at risk

Adverse event: Skin disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 107 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 107 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 107 at risk

Adverse event: Angiopathy
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 107 at risk