Study: NCT00493870

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 969 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 969 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 969 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 969 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 969 at risk

Adverse event: Neutrophil count
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 969 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 969 at risk

Adverse event: White blood cell count increased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 969 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 969 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 969 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 969 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 969 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 969 at risk

Adverse event: Chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 969 at risk

Adverse event: Malaise
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 969 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 969 at risk

Adverse event: Folliculitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 969 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 969 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 969 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 969 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 969 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 969 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 969 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 969 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 969 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 969 at risk

Adverse event: GI - OTHER (SPECIFY)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 969 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 969 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 969 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 969 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 969 at risk

Adverse event: Haematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 969 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 969 at risk

Adverse event: HEMORRHAGE, GI
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 969 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 969 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 969 at risk

Adverse event: Mastitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 969 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 969 at risk

Adverse event: Clostridial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 969 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 42 affected / 969 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Infections and infestations
Frequency: 21 affected / 969 at risk

Adverse event: INFECTION (DOCUMENTED CLINICALLY)
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 969 at risk

Adverse event: INFECTION - OTHER (SPECIFY)
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 969 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 969 at risk

Adverse event: INFECTION WITH NORMAL ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 969 at risk

Adverse event: Injection site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 969 at risk

Adverse event: OPPORTUNISITIC INFECTION
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 969 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 969 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 969 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 969 at risk

Adverse event: Oedema
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 969 at risk

Adverse event: CONCENTRATION ABNORMAL
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 969 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 969 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 969 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 969 at risk

Adverse event: Dysarthria
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 969 at risk

Adverse event: Extrapyramidal disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 969 at risk

Adverse event: Emotional distress
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 969 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 969 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 969 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 969 at risk

Adverse event: Amaurosis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 969 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 969 at risk

Adverse event: Back pain
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 969 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 969 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 969 at risk

Adverse event: Pain
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 969 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 969 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 969 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 969 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 969 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 969 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 969 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 969 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 969 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 969 at risk

Adverse event: Antidiuretic hormone abnormality
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 969 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 969 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 969 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 969 at risk

Adverse event: Heavy menstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 969 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 969 at risk

Adverse event: Vascular access complication
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 969 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 164 affected / 969 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 100 affected / 969 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 294 affected / 969 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 969 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 470 affected / 969 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 543 affected / 969 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 100 affected / 969 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 168 affected / 969 at risk

Adverse event: Hot flush
Serious: no
Organ System: Endocrine disorders
Frequency: 95 affected / 969 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 77 affected / 969 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 153 affected / 969 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 969 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 251 affected / 969 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 106 affected / 969 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 75 affected / 969 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 84 affected / 969 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 326 affected / 969 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 69 affected / 969 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 114 affected / 969 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 78 affected / 969 at risk

Adverse event: Bacterial infection
Serious: no
Organ System: Infections and infestations
Frequency: 43 affected / 969 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 969 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 188 affected / 969 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 53 affected / 969 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 63 affected / 969 at risk

Adverse event: Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 59 affected / 969 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 42 affected / 969 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 102 affected / 969 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 203 affected / 969 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 58 affected / 969 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Investigations
Frequency: 56 affected / 969 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Investigations
Frequency: 128 affected / 969 at risk

Adverse event: Back pain
Serious: no
Organ System: Investigations
Frequency: 52 affected / 969 at risk

Adverse event: Bone pain
Serious: no
Organ System: Investigations
Frequency: 113 affected / 969 at risk

Adverse event: Headache
Serious: no
Organ System: Investigations
Frequency: 112 affected / 969 at risk

Adverse event: Myalgia
Serious: no
Organ System: Investigations
Frequency: 144 affected / 969 at risk

Adverse event: Pain
Serious: no
Organ System: Investigations
Frequency: 185 affected / 969 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 65 affected / 969 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 76 affected / 969 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 54 affected / 969 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 965 at risk

Adverse event: Asthma
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 965 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 965 at risk

Adverse event: Circulatory collapse
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 965 at risk

Adverse event: Haemoglobin
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 965 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 965 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 965 at risk

Adverse event: Neutrophil count
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 965 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 965 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 965 at risk

Adverse event: DEFECT CONDUCT INTRAVENTRICULAR
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 965 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 965 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 965 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 965 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 965 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 965 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 965 at risk

Adverse event: CARDIAC GENERAL - OTHER (SPECIFY)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 965 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 965 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 965 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 965 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 965 at risk

Adverse event: Left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 965 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 965 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 965 at risk

Adverse event: BROKEN CATHETER ON PORT-A-CATH
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 965 at risk

Adverse event: Chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 965 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 965 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 965 at risk

Adverse event: Shock
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 965 at risk

Adverse event: N/A
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 965 at risk

Adverse event: Sudden death
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 965 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 965 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 965 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 965 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 965 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 965 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 965 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 965 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 965 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 965 at risk

Adverse event: GI - OTHER (SPECIFY)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 965 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 965 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 965 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 965 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 965 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 965 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 965 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 965 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 965 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 965 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 965 at risk

Adverse event: Anal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 965 at risk

Adverse event: Mastitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 965 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 965 at risk

Adverse event: Clostridial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 965 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 44 affected / 965 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 965 at risk

Adverse event: INFECTION (DOCUMENTED CLINICALLY)
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 965 at risk

Adverse event: INFECTION - OTHER (SPECIFY)
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 965 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 965 at risk

Adverse event: INFECTION WITH UNKNOWN ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 965 at risk

Adverse event: Injection site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 965 at risk

Adverse event: N/A
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 965 at risk

Adverse event: OPPORTUNISITIC INFECTION
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 965 at risk

Adverse event: Pelvic inflammatory disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 965 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 965 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 965 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 965 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 965 at risk

Adverse event: Oedema
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 965 at risk

Adverse event: Lymphadenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 965 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 965 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 965 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 965 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 965 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 965 at risk

Adverse event: DEVICE/PROSTHESIS
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 965 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 965 at risk

Adverse event: Depression
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 965 at risk

Adverse event: Mental impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 965 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 965 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 965 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 965 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 965 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 965 at risk

Adverse event: Aggression
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 965 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Investigations
Frequency: 10 affected / 965 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 965 at risk

Adverse event: Headache
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 965 at risk

Adverse event: Pain
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 965 at risk

Adverse event: Pelvic pain
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 965 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 965 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 965 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 965 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 965 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 965 at risk

Adverse event: Lung infiltration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 965 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 965 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 965 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 965 at risk

Adverse event: SECONDARY MALIGNANCY (POSSIBLY RELATED TO CANCER TREATME
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 965 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 965 at risk

Adverse event: Vascular access complication
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 965 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 183 affected / 965 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 92 affected / 965 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 243 affected / 965 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 72 affected / 965 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 498 affected / 965 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 538 affected / 965 at risk

Adverse event: Nail disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 58 affected / 965 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 94 affected / 965 at risk

Adverse event: Hot flush
Serious: no
Organ System: Endocrine disorders
Frequency: 80 affected / 965 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 107 affected / 965 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 175 affected / 965 at risk

Adverse event: Dehydration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 85 affected / 965 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 331 affected / 965 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 127 affected / 965 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 97 affected / 965 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 94 affected / 965 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 413 affected / 965 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 63 affected / 965 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 164 affected / 965 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 80 affected / 965 at risk

Adverse event: Bacterial infection
Serious: no
Organ System: Infections and infestations
Frequency: 50 affected / 965 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 51 affected / 965 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 142 affected / 965 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 56 affected / 965 at risk

Adverse event: Anxiety
Serious: no
Organ System: Nervous system disorders
Frequency: 56 affected / 965 at risk

Adverse event: Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 46 affected / 965 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 54 affected / 965 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 92 affected / 965 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 171 affected / 965 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 61 affected / 965 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Investigations
Frequency: 75 affected / 965 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Investigations
Frequency: 100 affected / 965 at risk

Adverse event: Back pain
Serious: no
Organ System: Investigations
Frequency: 52 affected / 965 at risk

Adverse event: Bone pain
Serious: no
Organ System: Investigations
Frequency: 104 affected / 965 at risk

Adverse event: Headache
Serious: no
Organ System: Investigations
Frequency: 112 affected / 965 at risk

Adverse event: Myalgia
Serious: no
Organ System: Investigations
Frequency: 109 affected / 965 at risk

Adverse event: Pain
Serious: no
Organ System: Investigations
Frequency: 139 affected / 965 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 66 affected / 965 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 88 affected / 965 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 37 affected / 965 at risk