Study: NCT01285609

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 21 affected / 475 at risk

Adverse event: Autoimmune colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 475 at risk

Adverse event: Blood pressure decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 475 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 475 at risk

Adverse event: Cholangitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 475 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 475 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 475 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 475 at risk

Adverse event: Dermatitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 475 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 475 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 475 at risk

Adverse event: Hepatotoxicity
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 475 at risk

Adverse event: Idiopathic pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 475 at risk

Adverse event: Lung infiltration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 475 at risk

Adverse event: Metastases to central nervous system
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 475 at risk

Adverse event: Neoplasm progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 475 at risk

Adverse event: Non-small cell lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 475 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 475 at risk

Adverse event: Performance status decreased
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 475 at risk

Adverse event: Peripheral sensory neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 475 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 475 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 475 at risk

Adverse event: Post procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 475 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 475 at risk

Adverse event: Spinal cord paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 475 at risk

Adverse event: Swelling face
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 475 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 475 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 475 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 475 at risk

Adverse event: Bile duct stenosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 475 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 475 at risk

Adverse event: Blood thyroid stimulating hormone decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 475 at risk

Adverse event: Bone marrow failure
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 475 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 475 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 475 at risk

Adverse event: Colorectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 475 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 475 at risk

Adverse event: Diverticular perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 475 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 475 at risk

Adverse event: Dysuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 475 at risk

Adverse event: Exfoliative rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 475 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 475 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 475 at risk

Adverse event: Hepatic function abnormal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 475 at risk

Adverse event: Hepatocellular injury
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 475 at risk

Adverse event: Hiccups
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 475 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 475 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 475 at risk

Adverse event: Malignant neoplasm progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 35 affected / 475 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 475 at risk

Adverse event: Pathological fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 475 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 475 at risk

Adverse event: Portal vein thrombosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 475 at risk

Adverse event: Anisocoria
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 475 at risk

Adverse event: Superior vena cava syndrome
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 475 at risk

Adverse event: Swelling
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 475 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 475 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 475 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 475 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 475 at risk

Adverse event: Agranulocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 475 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 475 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 475 at risk

Adverse event: Bronchostenosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 475 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 475 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 475 at risk

Adverse event: Cardiovascular insufficiency
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 475 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 475 at risk

Adverse event: Crohn's disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 475 at risk

Adverse event: Dermatitis acneiform
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 475 at risk

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 475 at risk

Adverse event: Fulminant type 1 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 475 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 475 at risk

Adverse event: Hypophysitis
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 475 at risk

Adverse event: Ileal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 475 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 475 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 475 at risk

Adverse event: Nasopharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 475 at risk

Adverse event: Neuroendocrine carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 475 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 475 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 475 at risk

Adverse event: Pulmonary sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 475 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 475 at risk

Adverse event: Shock haemorrhagic
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 475 at risk

Adverse event: Tachypnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 475 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 475 at risk

Adverse event: Viraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 475 at risk

Adverse event: Adrenocortical insufficiency acute
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 475 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 475 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 475 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 475 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 475 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 475 at risk

Adverse event: Empyema
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 475 at risk

Adverse event: Erythema multiforme
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 475 at risk

Adverse event: Extravasation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 475 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 475 at risk

Adverse event: Myocardial injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 475 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 475 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 475 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 475 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 475 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 475 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 475 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 475 at risk

Adverse event: Necrotising fasciitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 475 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 475 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 475 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 475 at risk

Adverse event: Pneumothorax spontaneous
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 475 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 21 affected / 475 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 475 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 475 at risk

Adverse event: Abdominal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 475 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 475 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 475 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 475 at risk

Adverse event: Body temperature increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 475 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 475 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 475 at risk

Adverse event: Circulatory collapse
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 475 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 475 at risk

Adverse event: Drug-induced liver injury
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 475 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 475 at risk

Adverse event: Febrile infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 475 at risk

Adverse event: Hepatitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 475 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 475 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 475 at risk

Adverse event: Hypopituitarism
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 475 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 475 at risk

Adverse event: Impaired gastric emptying
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 475 at risk

Adverse event: Infusion related reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 475 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 475 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 475 at risk

Adverse event: Lung abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 475 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 475 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 475 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 475 at risk

Adverse event: Superficial inflammatory dermatosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 475 at risk

Adverse event: Pneumocystis jirovecii pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 475 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 475 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 475 at risk

Adverse event: Spinal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 475 at risk

Adverse event: Thyroiditis
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 475 at risk

Adverse event: Tubulointerstitial nephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 475 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 475 at risk

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 475 at risk

Adverse event: Brain injury
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 475 at risk

Adverse event: Cachexia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 475 at risk

Adverse event: Cardiopulmonary failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 475 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 475 at risk

Adverse event: Chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 475 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 475 at risk

Adverse event: Hypersomnia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 475 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 475 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 475 at risk

Adverse event: Liver function test abnormal
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 475 at risk

Adverse event: Lung disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 475 at risk

Adverse event: Metastatic neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 475 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 475 at risk

Adverse event: Nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 475 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 475 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 37 affected / 475 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 475 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 475 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 475 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 475 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 475 at risk

Adverse event: Vena cava thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 475 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 475 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 475 at risk

Adverse event: Brain contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 475 at risk

Adverse event: Brain herniation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 475 at risk

Adverse event: C-reactive protein increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 475 at risk

Adverse event: Cancer pain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 475 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 475 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 475 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 475 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 475 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 475 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 475 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 475 at risk

Adverse event: Eczema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 475 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 475 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 475 at risk

Adverse event: Hypothalamo-pituitary disorder
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 475 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 475 at risk

Adverse event: Myositis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 475 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 475 at risk

Adverse event: Renal function test abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 475 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 475 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 475 at risk

Adverse event: Spinal column injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 475 at risk

Adverse event: Subileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 475 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 475 at risk

Adverse event: Superior vena cava occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 475 at risk

Adverse event: Tracheobronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 475 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 475 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 475 at risk

Adverse event: Acute hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 475 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 475 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 475 at risk

Adverse event: Colitis ischaemic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 475 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 475 at risk

Adverse event: Endocrine disorder
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 475 at risk

Adverse event: Erythema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 475 at risk

Adverse event: Facial paresis
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 475 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 475 at risk

Adverse event: General physical condition abnormal
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 475 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 475 at risk

Adverse event: Large intestine infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 475 at risk

Adverse event: Jaundice cholestatic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 475 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 475 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 475 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 475 at risk

Adverse event: Neutropenic sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 475 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 475 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 475 at risk

Adverse event: Polyneuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 475 at risk

Adverse event: Pulmonary artery stenosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 475 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 475 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 475 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 475 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 475 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 475 at risk

Adverse event: Systemic inflammatory response syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 475 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 475 at risk

Adverse event: Tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 475 at risk

Adverse event: Ulcerative keratitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 475 at risk

Adverse event: Guillain-Barre syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 475 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 171 affected / 475 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 145 affected / 475 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 38 affected / 475 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 66 affected / 475 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 25 affected / 475 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 71 affected / 475 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 25 affected / 475 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 34 affected / 475 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 80 affected / 475 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 32 affected / 475 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 26 affected / 475 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 475 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 44 affected / 475 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 30 affected / 475 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 44 affected / 475 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 77 affected / 475 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 181 affected / 475 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 34 affected / 475 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 475 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 61 affected / 475 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 10 affected / 475 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 475 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 61 affected / 475 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 47 affected / 475 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 91 affected / 475 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 89 affected / 475 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 475 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 37 affected / 475 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 475 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 35 affected / 475 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 94 affected / 475 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 37 affected / 475 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 78 affected / 475 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 77 affected / 475 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 82 affected / 475 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 51 affected / 475 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 87 affected / 475 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 34 affected / 475 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 117 affected / 475 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 145 affected / 475 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 142 affected / 475 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 475 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 152 affected / 475 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 107 affected / 475 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 31 affected / 475 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 43 affected / 475 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 475 at risk

Adverse event: Acute myeloid leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 473 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 473 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 473 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Autoimmune colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 473 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 473 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 473 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 473 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 473 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 473 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 473 at risk

Adverse event: Metastases to central nervous system
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 473 at risk

Adverse event: Non-small cell lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 473 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 473 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 473 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 473 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 473 at risk

Adverse event: Asbestosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 473 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 473 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 473 at risk

Adverse event: Bone marrow failure
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 473 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 473 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 473 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 473 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 473 at risk

Adverse event: Cholestasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 473 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 473 at risk

Adverse event: Embolism venous
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 473 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 473 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 473 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 473 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 473 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 473 at risk

Adverse event: Liver disorder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 473 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 473 at risk

Adverse event: Malignant neoplasm progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 37 affected / 473 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 473 at risk

Adverse event: Pathological fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 473 at risk

Adverse event: Pulmonary infarction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 473 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 473 at risk

Adverse event: Superior vena cava syndrome
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 473 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 473 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 473 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 473 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 473 at risk

Adverse event: Bronchial disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 473 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 473 at risk

Adverse event: Disease progression
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 473 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 473 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 473 at risk

Adverse event: Hydrocholecystis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 473 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 473 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 473 at risk

Adverse event: Peripheral embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 473 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 473 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 473 at risk

Adverse event: Radiation pneumonitis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 473 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 473 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 473 at risk

Adverse event: Traumatic haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 473 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 473 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 473 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 473 at risk

Adverse event: Cervical radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 473 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 473 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 473 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 473 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 473 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 473 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 473 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 473 at risk

Adverse event: Lung squamous cell carcinoma metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 473 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 473 at risk

Adverse event: Partial seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 473 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 473 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 473 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 14 affected / 473 at risk

Adverse event: Red blood cell count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 473 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 473 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 473 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 473 at risk

Adverse event: Small intestine carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 473 at risk

Adverse event: Tumour lysis syndrome
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 473 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 473 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 473 at risk

Adverse event: Bronchitis chronic
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 473 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 473 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 473 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 473 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 473 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 473 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 473 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 473 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 473 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 473 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 473 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 473 at risk

Adverse event: Lumbar vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 473 at risk

Adverse event: Lung abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 473 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 473 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 8 affected / 473 at risk

Adverse event: Metastases to meninges
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 473 at risk

Adverse event: Orchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 473 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 473 at risk

Adverse event: Anaemia of malignant disease
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 473 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 473 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 473 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 473 at risk

Adverse event: Depressed mood
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 473 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 473 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 473 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 473 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 473 at risk

Adverse event: Lung cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 473 at risk

Adverse event: Malaise
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 473 at risk

Adverse event: Neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 473 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 473 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 473 at risk

Adverse event: Peripheral motor neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 473 at risk

Adverse event: Pneumococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 473 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 34 affected / 473 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 473 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 473 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 473 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 473 at risk

Adverse event: Tumour compression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 473 at risk

Adverse event: Azotaemia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 473 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 473 at risk

Adverse event: C-reactive protein increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 473 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 473 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 473 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 473 at risk

Adverse event: Device occlusion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 473 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 473 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 473 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 473 at risk

Adverse event: Blood loss anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 473 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 473 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 473 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 473 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 473 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 473 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 473 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 473 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 473 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 473 at risk

Adverse event: Tumour perforation
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 473 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 473 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 473 at risk

Adverse event: Blood glucose increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 473 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 473 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 473 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 473 at risk

Adverse event: General physical condition abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 473 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 473 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 473 at risk

Adverse event: Metastases to liver
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 473 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 473 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 473 at risk

Adverse event: Neutropenic sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 473 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 473 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 473 at risk

Adverse event: Phlebitis superficial
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 473 at risk

Adverse event: Polyneuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 473 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 473 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 473 at risk

Adverse event: Type 2 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 473 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 157 affected / 473 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 116 affected / 473 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 30 affected / 473 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 61 affected / 473 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 31 affected / 473 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 98 affected / 473 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 31 affected / 473 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 20 affected / 473 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 55 affected / 473 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 473 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 45 affected / 473 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 473 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 27 affected / 473 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 473 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 54 affected / 473 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 70 affected / 473 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 175 affected / 473 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 41 affected / 473 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 473 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 49 affected / 473 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: General disorders
Frequency: 27 affected / 473 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 473 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 57 affected / 473 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 32 affected / 473 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 70 affected / 473 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 68 affected / 473 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 473 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 26 affected / 473 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 473 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 58 affected / 473 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 97 affected / 473 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 473 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 473 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 58 affected / 473 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 85 affected / 473 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 31 affected / 473 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 45 affected / 473 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 38 affected / 473 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 103 affected / 473 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 89 affected / 473 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 140 affected / 473 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 473 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 151 affected / 473 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 102 affected / 473 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 31 affected / 473 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 43 affected / 473 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 473 at risk