Study: NCT03139604

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 215 at risk

Adverse event: Acute graft versus host disease
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 215 at risk

Adverse event: Acute graft versus host disease in skin
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 215 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 215 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 215 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 215 at risk

Adverse event: Adenovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 215 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 215 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 215 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 215 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 215 at risk

Adverse event: Aspergillus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 215 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 215 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 215 at risk

Adverse event: BK virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Bicytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 215 at risk

Adverse event: Blood fibrinogen decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 215 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Bronchopulmonary aspergillosis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 215 at risk

Adverse event: Cachexia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 215 at risk

Adverse event: Cerebral toxoplasmosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 215 at risk

Adverse event: Chronic lymphocytic leukaemia recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 215 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 215 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Cystitis haemorrhagic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 215 at risk

Adverse event: Cytomegalovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 215 at risk

Adverse event: Cytomegalovirus infection reactivation
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 215 at risk

Adverse event: Cytomegalovirus viraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 215 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 215 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 215 at risk

Adverse event: Diverticular perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 215 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Dysuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 215 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 215 at risk

Adverse event: Epstein-Barr virus infection reactivation
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Escherichia infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Escherichia sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 215 at risk

Adverse event: Extradural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 215 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 215 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 215 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 215 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 215 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 215 at risk

Adverse event: Fungal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Gastritis erosive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 215 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 215 at risk

Adverse event: Graft versus host disease
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 215 at risk

Adverse event: Graft versus host disease in gastrointestinal tract
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 215 at risk

Adverse event: Haemoperitoneum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 215 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 215 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 215 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Hypercholesterolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 215 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 215 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 215 at risk

Adverse event: Hypertriglyceridaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 215 at risk

Adverse event: Hypofibrinogenaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 215 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 215 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 215 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 215 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Large intestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 215 at risk

Adverse event: Lethargy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 215 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 215 at risk

Adverse event: Malignant neoplasm progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 215 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 215 at risk

Adverse event: Microangiopathy
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 215 at risk

Adverse event: Mucormycosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 215 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 215 at risk

Adverse event: Myeloid leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 215 at risk

Adverse event: Myopathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 215 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 215 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 215 at risk

Adverse event: Neutropenic sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 215 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 215 at risk

Adverse event: Ophthalmic herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 215 at risk

Adverse event: Oral herpes
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 215 at risk

Adverse event: Organising pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 215 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 215 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 215 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 215 at risk

Adverse event: Peripheral motor neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 215 at risk

Adverse event: Photophobia
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 215 at risk

Adverse event: Pleuritic pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 215 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 215 at risk

Adverse event: Pneumonia cytomegaloviral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Pneumonia influenzal
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 215 at risk

Adverse event: Pneumonia necrotising
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 215 at risk

Adverse event: Post transplant lymphoproliferative disorder
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 215 at risk

Adverse event: Posterior reversible encephalopathy syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 215 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 215 at risk

Adverse event: Pseudomonal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 215 at risk

Adverse event: Pseudomonas infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 215 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 15 affected / 215 at risk

Adverse event: Rash maculo-papular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 215 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 215 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 215 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Respiratory tract infection fungal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 215 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 215 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Staphylococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Steroid diabetes
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 215 at risk

Adverse event: Substance-induced psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 215 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 215 at risk

Adverse event: T-cell lymphoma recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 215 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 215 at risk

Adverse event: Thrombotic microangiopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 215 at risk

Adverse event: Toxic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 215 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 215 at risk

Adverse event: Viral haemorrhagic cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 215 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 215 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 215 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 215 at risk

Adverse event: Adenoviral hepatitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Agranulocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 215 at risk

Adverse event: Anal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 215 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 215 at risk

Adverse event: Bartter's syndrome
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 215 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 215 at risk

Adverse event: Bone marrow failure
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 215 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 215 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 215 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 215 at risk

Adverse event: Diabetic coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 215 at risk

Adverse event: Disseminated aspergillosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Electrocardiogram T wave abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 215 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 215 at risk

Adverse event: Enterococcus test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 215 at risk

Adverse event: Epstein-Barr virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Gastrointestinal candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 215 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 215 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 215 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 215 at risk

Adverse event: Klebsiella sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Leukaemia recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 215 at risk

Adverse event: Encephalitis herpes
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 215 at risk

Adverse event: Parainfluenzae virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 215 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 215 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 215 at risk

Adverse event: Status epilepticus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 215 at risk

Adverse event: Transplant dysfunction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 215 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 215 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 215 at risk

Adverse event: Vascular device infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 215 at risk

Adverse event: Venoocclusive liver disease
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 215 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 215 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 215 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 11 affected / 215 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 30 affected / 215 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 63 affected / 215 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 23 affected / 215 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 23 affected / 215 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 12 affected / 215 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 215 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 215 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 16 affected / 215 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 25 affected / 215 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 215 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 32 affected / 215 at risk

Adverse event: Cytomegalovirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 215 at risk

Adverse event: Cytomegalovirus infection reactivation
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 215 at risk

Adverse event: Cytomegalovirus viraemia
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 215 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 215 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 215 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 215 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 18 affected / 215 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 215 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 28 affected / 215 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 17 affected / 215 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 20 affected / 215 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 28 affected / 215 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 215 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 215 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 47 affected / 215 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 215 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 46 affected / 215 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 31 affected / 215 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 215 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 215 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 40 affected / 215 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 215 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 215 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 215 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 22 affected / 215 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 23 affected / 215 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 215 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 36 affected / 215 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 7 affected / 215 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 53 affected / 215 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 215 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 38 affected / 215 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 215 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 34 affected / 215 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 215 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 73 affected / 215 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 215 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 215 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 215 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 215 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 17 affected / 215 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 215 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 215 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 215 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 215 at risk

Adverse event: Epstein-Barr virus infection reactivation
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 215 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 16 affected / 215 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 215 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 215 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 215 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 15 affected / 215 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 215 at risk

Adverse event: Pancytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 215 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 215 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 215 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 215 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 215 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 215 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 216 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Acute graft versus host disease
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 216 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 216 at risk

Adverse event: Acute myeloid leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 216 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 216 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 216 at risk

Adverse event: Acute sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Adenovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 216 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 216 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 216 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 216 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 216 at risk

Adverse event: BK virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 216 at risk

Adverse event: Bacterial sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 216 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 216 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 216 at risk

Adverse event: Bronchopulmonary aspergillosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Campylobacter infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Cholecystitis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 216 at risk

Adverse event: Clostridium difficile infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 216 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 216 at risk

Adverse event: Cytomegalovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 216 at risk

Adverse event: Cytomegalovirus infection reactivation
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Cytomegalovirus viraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 216 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 216 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 216 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Dyspnoea exertional
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 216 at risk

Adverse event: Dysuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 216 at risk

Adverse event: Ecchymosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 216 at risk

Adverse event: Encephalitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 216 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 216 at risk

Adverse event: Enterovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 216 at risk

Adverse event: Epstein-Barr virus infection reactivation
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Escherichia infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Escherichia sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 216 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 216 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 216 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 216 at risk

Adverse event: Fungal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Gastroenteritis norovirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Gastrointestinal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Graft versus host disease
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 216 at risk

Adverse event: Graft versus host disease in gastrointestinal tract
Serious: yes
Organ System: Immune system disorders
Frequency: 6 affected / 216 at risk

Adverse event: Graft versus host disease in lung
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 216 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 216 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 216 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 216 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 216 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 216 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 216 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 216 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 216 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 216 at risk

Adverse event: Encephalitis autoimmune
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 216 at risk

Adverse event: Liver function test increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 216 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 216 at risk

Adverse event: Lower respiratory tract infection fungal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Malignant neoplasm progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 216 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 216 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 216 at risk

Adverse event: Microangiopathic haemolytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 216 at risk

Adverse event: Microangiopathy
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 216 at risk

Adverse event: Mucormycosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 216 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 216 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 216 at risk

Adverse event: Myelodysplastic syndrome
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 216 at risk

Adverse event: Myopathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 216 at risk

Adverse event: Nasal cavity cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 216 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 216 at risk

Adverse event: Neurotoxicity
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 216 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 216 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 216 at risk

Adverse event: Obliterative bronchiolitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 216 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 216 at risk

Adverse event: Oral candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Organising pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 216 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 216 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 216 at risk

Adverse event: Pneumatosis intestinalis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 216 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 216 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Pneumonia cytomegaloviral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Pneumonia pneumococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Pneumonia pseudomonal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 216 at risk

Adverse event: Post transplant lymphoproliferative disorder
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 216 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 216 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 216 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 216 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 216 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Rhinovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 216 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 216 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 216 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Soft tissue necrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 216 at risk

Adverse event: Staphylococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 216 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 216 at risk

Adverse event: Testicular pain
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 216 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 216 at risk

Adverse event: Thrombotic microangiopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 216 at risk

Adverse event: Toxic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 216 at risk

Adverse event: Toxoplasmosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Varicella zoster virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Viral diarrhoea
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 216 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 216 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Acute graft versus host disease in intestine
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 216 at risk

Adverse event: Acute myeloid leukaemia recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 216 at risk

Adverse event: Altered state of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 216 at risk

Adverse event: Amyotrophy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 216 at risk

Adverse event: Anal inflammation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 216 at risk

Adverse event: Arthritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 216 at risk

Adverse event: Blast cell crisis
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 216 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 216 at risk

Adverse event: Bullous oedema of the bladder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 216 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 216 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 216 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 216 at risk

Adverse event: Clostridium test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 216 at risk

Adverse event: Coronavirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Cytomegalovirus colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Enterococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 216 at risk

Adverse event: Escherichia bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Fungal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 216 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 216 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 216 at risk

Adverse event: Klebsiella sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Klebsiella test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 216 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 216 at risk

Adverse event: Polyneuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 216 at risk

Adverse event: Pseudomonal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Pulmonary alveolar haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 216 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Rotavirus test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 216 at risk

Adverse event: Sepsis syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 216 at risk

Adverse event: Sinusitis aspergillus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Sinusitis fungal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Spinal subdural haematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 216 at risk

Adverse event: Streptococcal urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 216 at risk

Adverse event: Transaminases increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 216 at risk

Adverse event: Transplant failure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 216 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 216 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 216 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 21 affected / 216 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 21 affected / 216 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 54 affected / 216 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 216 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 13 affected / 216 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 19 affected / 216 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 216 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 16 affected / 216 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 216 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 19 affected / 216 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 216 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 42 affected / 216 at risk

Adverse event: Cytomegalovirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 216 at risk

Adverse event: Cytomegalovirus infection reactivation
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 216 at risk

Adverse event: Cytomegalovirus viraemia
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 216 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 216 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 43 affected / 216 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 216 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 17 affected / 216 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 216 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 216 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 216 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 21 affected / 216 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 37 affected / 216 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 216 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 32 affected / 216 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 50 affected / 216 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 216 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 31 affected / 216 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 216 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 23 affected / 216 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 216 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 35 affected / 216 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 216 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 216 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 216 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 25 affected / 216 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 216 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 216 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 40 affected / 216 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 16 affected / 216 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 53 affected / 216 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 216 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 22 affected / 216 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 216 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 31 affected / 216 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 216 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 69 affected / 216 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 216 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 216 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 216 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 216 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 216 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 216 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 216 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 216 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 216 at risk

Adverse event: Epstein-Barr virus infection reactivation
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 216 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 216 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 216 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 216 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 216 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 216 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 216 at risk

Adverse event: Pancytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 216 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 216 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 216 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 216 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 216 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 216 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 431 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Acute graft versus host disease
Serious: yes
Organ System: Immune system disorders
Frequency: 4 affected / 431 at risk

Adverse event: Acute graft versus host disease in skin
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 431 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 13 affected / 431 at risk

Adverse event: Acute myeloid leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 431 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 431 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 431 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 431 at risk

Adverse event: Acute sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Adenovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 431 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 431 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 431 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 431 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 431 at risk

Adverse event: Aspergillus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 431 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 431 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 431 at risk

Adverse event: BK virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 431 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 431 at risk

Adverse event: Bacterial sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 431 at risk

Adverse event: Bicytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 431 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 431 at risk

Adverse event: Blood fibrinogen decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 431 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 431 at risk

Adverse event: Bronchopulmonary aspergillosis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 431 at risk

Adverse event: Cachexia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 431 at risk

Adverse event: Campylobacter infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Cerebral toxoplasmosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 431 at risk

Adverse event: Cholecystitis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Chronic lymphocytic leukaemia recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 431 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 431 at risk

Adverse event: Clostridium difficile infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 431 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 431 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Cystitis haemorrhagic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 431 at risk

Adverse event: Cytomegalovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 431 at risk

Adverse event: Cytomegalovirus infection reactivation
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 431 at risk

Adverse event: Cytomegalovirus viraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 431 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 431 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 431 at risk

Adverse event: Diverticular perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 431 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 431 at risk

Adverse event: Dyspnoea exertional
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 431 at risk

Adverse event: Dysuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 431 at risk

Adverse event: Ecchymosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 431 at risk

Adverse event: Encephalitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 431 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 431 at risk

Adverse event: Enterovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 431 at risk

Adverse event: Epstein-Barr virus infection reactivation
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 431 at risk

Adverse event: Escherichia infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 431 at risk

Adverse event: Escherichia sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 431 at risk

Adverse event: Extradural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 431 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 431 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 431 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 431 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 431 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 431 at risk

Adverse event: Fungal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 431 at risk

Adverse event: Gastritis erosive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 431 at risk

Adverse event: Gastroenteritis norovirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Gastrointestinal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 431 at risk

Adverse event: Graft versus host disease
Serious: yes
Organ System: Immune system disorders
Frequency: 4 affected / 431 at risk

Adverse event: Graft versus host disease in gastrointestinal tract
Serious: yes
Organ System: Immune system disorders
Frequency: 9 affected / 431 at risk

Adverse event: Graft versus host disease in lung
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 431 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 431 at risk

Adverse event: Haemoperitoneum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 431 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 431 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 431 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 431 at risk

Adverse event: Hypercholesterolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 431 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 431 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 431 at risk

Adverse event: Hypertriglyceridaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 431 at risk

Adverse event: Hypofibrinogenaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 431 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 431 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 431 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 431 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 431 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 431 at risk

Adverse event: Large intestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 431 at risk

Adverse event: Lethargy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 431 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 431 at risk

Adverse event: Encephalitis autoimmune
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 431 at risk

Adverse event: Liver function test increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 431 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 431 at risk

Adverse event: Lower respiratory tract infection fungal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Malignant neoplasm progression
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 431 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 431 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 431 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 431 at risk

Adverse event: Microangiopathic haemolytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 431 at risk

Adverse event: Microangiopathy
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 431 at risk

Adverse event: Mucormycosis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 431 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 431 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 431 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 431 at risk

Adverse event: Myelodysplastic syndrome
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 431 at risk

Adverse event: Myeloid leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 431 at risk

Adverse event: Myopathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 431 at risk

Adverse event: Nasal cavity cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 431 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 431 at risk

Adverse event: Neurotoxicity
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 431 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 431 at risk

Adverse event: Neutropenic sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 431 at risk

Adverse event: Obliterative bronchiolitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 431 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 431 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 431 at risk

Adverse event: Ophthalmic herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 431 at risk

Adverse event: Oral candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Oral herpes
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 431 at risk

Adverse event: Organising pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 431 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 431 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 431 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 431 at risk

Adverse event: Peripheral motor neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 431 at risk

Adverse event: Photophobia
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 431 at risk

Adverse event: Pleuritic pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 431 at risk

Adverse event: Pneumatosis intestinalis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 431 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 24 affected / 431 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Pneumonia cytomegaloviral
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 431 at risk

Adverse event: Pneumonia influenzal
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 431 at risk

Adverse event: Pneumonia necrotising
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Pneumonia pneumococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Pneumonia pseudomonal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 431 at risk

Adverse event: Post transplant lymphoproliferative disorder
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 431 at risk

Adverse event: Posterior reversible encephalopathy syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 431 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 431 at risk

Adverse event: Pseudomonal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 431 at risk

Adverse event: Pseudomonas infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 431 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 25 affected / 431 at risk

Adverse event: Rash maculo-papular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 431 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 431 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 431 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 431 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Respiratory tract infection fungal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Rhinovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 431 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 431 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 431 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 431 at risk

Adverse event: Soft tissue necrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 431 at risk

Adverse event: Staphylococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 431 at risk

Adverse event: Steroid diabetes
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 431 at risk

Adverse event: Substance-induced psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 431 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 431 at risk

Adverse event: T-cell lymphoma recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 431 at risk

Adverse event: Testicular pain
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 431 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 431 at risk

Adverse event: Thrombotic microangiopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 431 at risk

Adverse event: Toxic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 431 at risk

Adverse event: Toxoplasmosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 431 at risk

Adverse event: Varicella zoster virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Viral diarrhoea
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Viral haemorrhagic cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 431 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 431 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 431 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 431 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 431 at risk

Adverse event: Acute graft versus host disease in intestine
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 431 at risk

Adverse event: Acute myeloid leukaemia recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 431 at risk

Adverse event: Adenoviral hepatitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Agranulocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 431 at risk

Adverse event: Altered state of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 431 at risk

Adverse event: Amyotrophy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 431 at risk

Adverse event: Anal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 431 at risk

Adverse event: Anal inflammation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 431 at risk

Adverse event: Arthritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 431 at risk

Adverse event: Bartter's syndrome
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 431 at risk

Adverse event: Blast cell crisis
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 431 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 431 at risk

Adverse event: Bone marrow failure
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 431 at risk

Adverse event: Bullous oedema of the bladder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 431 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 431 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 431 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 431 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 431 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 431 at risk

Adverse event: Clostridium test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 431 at risk

Adverse event: Coronavirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Cytomegalovirus colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Diabetic coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 431 at risk

Adverse event: Disseminated aspergillosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Electrocardiogram T wave abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 431 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 431 at risk

Adverse event: Enterococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 431 at risk

Adverse event: Enterococcus test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 431 at risk

Adverse event: Epstein-Barr virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Escherichia bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Fungal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Gastrointestinal candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 431 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 431 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 431 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 431 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 431 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 431 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 431 at risk

Adverse event: Klebsiella sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 431 at risk

Adverse event: Klebsiella test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 431 at risk

Adverse event: Leukaemia recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 431 at risk

Adverse event: Encephalitis herpes
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 431 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Parainfluenzae virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 431 at risk

Adverse event: Polyneuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 431 at risk

Adverse event: Pseudomonal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Pulmonary alveolar haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 431 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 431 at risk

Adverse event: Rotavirus test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 431 at risk

Adverse event: Sepsis syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 431 at risk

Adverse event: Sinusitis aspergillus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Sinusitis fungal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 431 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 431 at risk

Adverse event: Spinal subdural haematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 431 at risk

Adverse event: Status epilepticus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 431 at risk

Adverse event: Streptococcal urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 431 at risk

Adverse event: Transaminases increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 431 at risk

Adverse event: Transplant dysfunction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 431 at risk

Adverse event: Transplant failure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 431 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 431 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 431 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Vascular device infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 431 at risk

Adverse event: Venoocclusive liver disease
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 431 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 431 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 52 affected / 431 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 32 affected / 431 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 51 affected / 431 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 117 affected / 431 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 41 affected / 431 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 36 affected / 431 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 31 affected / 431 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 38 affected / 431 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 28 affected / 431 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 27 affected / 431 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 44 affected / 431 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 431 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 74 affected / 431 at risk

Adverse event: Cytomegalovirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 431 at risk

Adverse event: Cytomegalovirus infection reactivation
Serious: no
Organ System: Infections and infestations
Frequency: 50 affected / 431 at risk

Adverse event: Cytomegalovirus viraemia
Serious: no
Organ System: Infections and infestations
Frequency: 60 affected / 431 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 47 affected / 431 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 85 affected / 431 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 40 affected / 431 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 35 affected / 431 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 32 affected / 431 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 43 affected / 431 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 25 affected / 431 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 41 affected / 431 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 65 affected / 431 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 18 affected / 431 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 52 affected / 431 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 97 affected / 431 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 431 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 77 affected / 431 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 58 affected / 431 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 35 affected / 431 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 36 affected / 431 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 75 affected / 431 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 48 affected / 431 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 38 affected / 431 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 431 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 47 affected / 431 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 42 affected / 431 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 71 affected / 431 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 76 affected / 431 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 23 affected / 431 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 106 affected / 431 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 27 affected / 431 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 60 affected / 431 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 30 affected / 431 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 65 affected / 431 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 431 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 142 affected / 431 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 46 affected / 431 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 431 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 32 affected / 431 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 431 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 30 affected / 431 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 431 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 431 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 431 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 431 at risk

Adverse event: Epstein-Barr virus infection reactivation
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 431 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 27 affected / 431 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 431 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 431 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 431 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 24 affected / 431 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 431 at risk

Adverse event: Pancytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 431 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 431 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 431 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 19 affected / 431 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 19 affected / 431 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 22 affected / 431 at risk