Study: NCT00338286

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 1045 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 29 affected / 1045 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 1045 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 55 affected / 1045 at risk

Adverse event: Neutrophilia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 1045 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 1045 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1045 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1045 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1045 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1045 at risk

Adverse event: Cardiac failure chronic
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1045 at risk

Adverse event: Cardiopulmonary failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Cardiovascular insufficiency
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Myocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Amaurosis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Retinal artery thrombosis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1045 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1045 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 1045 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Haematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Mouth ulceration
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Peptic ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Proctitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1045 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 1045 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 1045 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1045 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Facial pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 1045 at risk

Adverse event: Malaise
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1045 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 1045 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 1045 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1045 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Peripheral swelling
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 1045 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 1045 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 1045 at risk

Adverse event: Hepatic lesion
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Hepatorenal syndrome
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Jaundice hepatocellular
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Amoebiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1045 at risk

Adverse event: Breast abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1045 at risk

Adverse event: Breast cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1045 at risk

Adverse event: Candida infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1045 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 1045 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1045 at risk

Adverse event: Fungal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1045 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1045 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1045 at risk

Adverse event: Injection site abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1045 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1045 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1045 at risk

Adverse event: Neutropenic sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1045 at risk

Adverse event: Oropharyngeal candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1045 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 1045 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1045 at risk

Adverse event: Respiratory tract infection viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1045 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 1045 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1045 at risk

Adverse event: Tuberculosis gastrointestinal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1045 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1045 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1045 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1045 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1045 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1045 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1045 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1045 at risk

Adverse event: Radius fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1045 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1045 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1045 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 1045 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1045 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1045 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Pain in jaw
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Soft tissue necrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Lymphangiosis carcinomatosa
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1045 at risk

Adverse event: Metastases to central nervous system
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1045 at risk

Adverse event: Metastases to meninges
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1045 at risk

Adverse event: Metastases to the respiratory system
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1045 at risk

Adverse event: Rectal adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1045 at risk

Adverse event: Tumour haemorrhage
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1045 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1045 at risk

Adverse event: Central nervous system haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1045 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1045 at risk

Adverse event: Dysarthria
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 1045 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Hemiplegia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1045 at risk

Adverse event: Hepatic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1045 at risk

Adverse event: IIIrd nerve paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Intracranial pressure increased
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1045 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Peripheral motor neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Peripheral sensorimotor neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 1045 at risk

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 1045 at risk

Adverse event: Device breakage
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1045 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 1045 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1045 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Breast mass
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Pelvic pain
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1045 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1045 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1045 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1045 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1045 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 1045 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Hydrothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 1045 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1045 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 1045 at risk

Adverse event: Respiratory acidosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1045 at risk

Adverse event: Palmar-plantar erythrodysaesthesia syndrome
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Petechiae
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Stevens-Johnson syndrome
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 1045 at risk

Adverse event: Hypovolaemic shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Phlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Vena cava thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Venous thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1045 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 153 affected / 1045 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 279 affected / 1045 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 550 affected / 1045 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 97 affected / 1045 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 1045 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 189 affected / 1045 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 1045 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 232 affected / 1045 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 79 affected / 1045 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 113 affected / 1045 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 139 affected / 1045 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 215 affected / 1045 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 81 affected / 1045 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 115 affected / 1045 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 67 affected / 1045 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 66 affected / 1045 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 190 affected / 1045 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 81 affected / 1045 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 54 affected / 1045 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 59 affected / 1045 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 56 affected / 1045 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 74 affected / 1045 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 74 affected / 1045 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 111 affected / 1045 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 95 affected / 1045 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 74 affected / 1045 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 326 affected / 1045 at risk

Adverse event: Agranulocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 1051 at risk

Adverse event: Bone marrow failure
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 40 affected / 1051 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 1051 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 52 affected / 1051 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 1051 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 1051 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1051 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Arteriosclerosis coronary artery
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Cardiac disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1051 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1051 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1051 at risk

Adverse event: Cardiopulmonary failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1051 at risk

Adverse event: Cyanosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 1051 at risk

Adverse event: Vision blurred
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Abdominal discomfort
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1051 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1051 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1051 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 1051 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1051 at risk

Adverse event: Gastrointestinal toxicity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1051 at risk

Adverse event: Jejunal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1051 at risk

Adverse event: Oral pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1051 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 1051 at risk

Adverse event: Gait inability
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 1051 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 1051 at risk

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 1051 at risk

Adverse event: Generalised oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1051 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1051 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1051 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 1051 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1051 at risk

Adverse event: Acute hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 1051 at risk

Adverse event: Cholecystitis chronic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Hepatitis toxic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Hepatomegaly
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 1051 at risk

Adverse event: Abdominal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1051 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1051 at risk

Adverse event: Biliary sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1051 at risk

Adverse event: Breast cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1051 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1051 at risk

Adverse event: Bronchopulmonary aspergillosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1051 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1051 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1051 at risk

Adverse event: Groin abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1051 at risk

Adverse event: Hepatitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1051 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1051 at risk

Adverse event: Infectious pleural effusion
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1051 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1051 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1051 at risk

Adverse event: Mastitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1051 at risk

Adverse event: Neutropenic infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1051 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1051 at risk

Adverse event: Plasmodium falciparum infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1051 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 1051 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1051 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1051 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 1051 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1051 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1051 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1051 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1051 at risk

Adverse event: Radius fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1051 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1051 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1051 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1051 at risk

Adverse event: Biopsy liver
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1051 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 1051 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Hypoalbuminaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1051 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 1051 at risk

Adverse event: Hypoproteinaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Pathological fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 1051 at risk

Adverse event: Cervix carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1051 at risk

Adverse event: Malignant pleural effusion
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1051 at risk

Adverse event: Metastases to central nervous system
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 10 affected / 1051 at risk

Adverse event: Metastases to liver
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1051 at risk

Adverse event: Metastases to meninges
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1051 at risk

Adverse event: Oncologic complication
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1051 at risk

Adverse event: Sarcoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1051 at risk

Adverse event: Tumour haemorrhage
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1051 at risk

Adverse event: Altered state of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1051 at risk

Adverse event: Diabetic hyperglycaemic coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Dysarthria
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1051 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Haemorrhagic cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 1051 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Hypoxic-ischaemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Incoherent
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Monoparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1051 at risk

Adverse event: Peripheral motor neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1051 at risk

Adverse event: Peripheral sensory neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1051 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 1051 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1051 at risk

Adverse event: Vertebral artery thrombosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Abnormal behaviour
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Depressed mood
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Ovarian cyst torsion
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Uterine polyp
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1051 at risk

Adverse event: Hypersensitivity pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 1051 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Oropharyngeal pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Orthopnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 1051 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1051 at risk

Adverse event: Pulmonary artery thrombosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 1051 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Pulmonary infarction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Pulmonary thrombosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1051 at risk

Adverse event: Restrictive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Blister
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Dermatitis exfoliative
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Intertrigo
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1051 at risk

Adverse event: Skin lesion
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1051 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1051 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 1051 at risk

Adverse event: Superior vena cava syndrome
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1051 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 98 affected / 1051 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 270 affected / 1051 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 530 affected / 1051 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 95 affected / 1051 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 53 affected / 1051 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 180 affected / 1051 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 57 affected / 1051 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 257 affected / 1051 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 71 affected / 1051 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 99 affected / 1051 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 131 affected / 1051 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 201 affected / 1051 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 73 affected / 1051 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 121 affected / 1051 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 71 affected / 1051 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 77 affected / 1051 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 182 affected / 1051 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 56 affected / 1051 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 55 affected / 1051 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 66 affected / 1051 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 74 affected / 1051 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 89 affected / 1051 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 83 affected / 1051 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 97 affected / 1051 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 122 affected / 1051 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 77 affected / 1051 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 314 affected / 1051 at risk