Study: NCT02723591

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 288 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 288 at risk

Adverse event: Blood loss anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 288 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 288 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 288 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 288 at risk

Adverse event: Thrombotic microangiopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 288 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 288 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 288 at risk

Adverse event: Aortic valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 288 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 288 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 288 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 288 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 288 at risk

Adverse event: Left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 288 at risk

Adverse event: Pulseless electrical activity
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 288 at risk

Adverse event: Supraventricular extrasystoles
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 288 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 288 at risk

Adverse event: Hyperparathyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 288 at risk

Adverse event: Hyperparathyroidism tertiary
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 288 at risk

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 288 at risk

Adverse event: Abdominal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 288 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 288 at risk

Adverse event: Abdominal pain lower
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 288 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 288 at risk

Adverse event: Diabetic gastroparesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 288 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 288 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 288 at risk

Adverse event: Hiatus hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 288 at risk

Adverse event: Impaired gastric emptying
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 288 at risk

Adverse event: Intra-abdominal fluid collection
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 288 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 288 at risk

Adverse event: Obstructive pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 288 at risk

Adverse event: Odynophagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 288 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 288 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 288 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 288 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 288 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 288 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 288 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 288 at risk

Adverse event: Haemorrhagic cyst
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 288 at risk

Adverse event: Implant site extravasation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 288 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 288 at risk

Adverse event: Peripheral swelling
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 288 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 288 at risk

Adverse event: Biliary tract disorder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 288 at risk

Adverse event: Hepatitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 288 at risk

Adverse event: Hepatitis alcoholic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 288 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 288 at risk

Adverse event: Kidney transplant rejection
Serious: yes
Organ System: Immune system disorders
Frequency: 12 affected / 288 at risk

Adverse event: Transplant rejection
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 288 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 288 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 288 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 288 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 288 at risk

Adverse event: Clostridium difficile infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 288 at risk

Adverse event: Coccidioidomycosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 288 at risk

Adverse event: Cytomegalovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 288 at risk

Adverse event: Cytomegalovirus viraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 288 at risk

Adverse event: Diabetic foot infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 288 at risk

Adverse event: Enterobacter bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 288 at risk

Adverse event: Enterococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 288 at risk

Adverse event: Enterovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 288 at risk

Adverse event: Escherichia urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 288 at risk

Adverse event: Fungal oesophagitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 288 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 288 at risk

Adverse event: Gastroenteritis norovirus
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 288 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 288 at risk

Adverse event: Infected cyst
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 288 at risk

Adverse event: Infection in an immunocompromised host
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 288 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 288 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 288 at risk

Adverse event: Necrotising soft tissue infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 288 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 288 at risk

Adverse event: Paronychia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 288 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 288 at risk

Adverse event: Peritonitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 288 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 288 at risk

Adverse event: Pneumonia klebsiella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 288 at risk

Adverse event: Pneumonia legionella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 288 at risk

Adverse event: Pneumonia pseudomonal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 288 at risk

Adverse event: Polyomavirus-associated nephropathy
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 288 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 288 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 288 at risk

Adverse event: Rhinovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 288 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 288 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 288 at risk

Adverse event: Streptococcal urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 288 at risk

Adverse event: Tooth infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 288 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 288 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 16 affected / 288 at risk

Adverse event: Urinary tract infection bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 288 at risk

Adverse event: Urinary tract infection enterococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 288 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 288 at risk

Adverse event: Viral pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 288 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 288 at risk

Adverse event: Wound infection staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 288 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 288 at risk

Adverse event: Complications of transplanted kidney
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 288 at risk

Adverse event: Delayed graft function
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 288 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 288 at risk

Adverse event: Graft complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 288 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 288 at risk

Adverse event: Incision site pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 288 at risk

Adverse event: Incisional hernia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 288 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 288 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 288 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 288 at risk

Adverse event: Pelvic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 288 at risk

Adverse event: Post procedural haematuria
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 288 at risk

Adverse event: Seroma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 288 at risk

Adverse event: Thoracic vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 288 at risk

Adverse event: Ureteric anastomosis complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 288 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 288 at risk

Adverse event: Wound haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 288 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 10 affected / 288 at risk

Adverse event: Blood potassium increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 288 at risk

Adverse event: Clostridium test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 288 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 288 at risk

Adverse event: Histology abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 288 at risk

Adverse event: Mycobacterium test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 288 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 288 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 288 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 288 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 288 at risk

Adverse event: Hyperglycaemic hyperosmolar nonketotic syndrome
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 288 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 288 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 288 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 288 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 288 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 288 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 288 at risk

Adverse event: Hypophosphataemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 288 at risk

Adverse event: Hypovolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 288 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 288 at risk

Adverse event: Type 1 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 288 at risk

Adverse event: Flank pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 288 at risk

Adverse event: Intervertebral disc degeneration
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 288 at risk

Adverse event: Mobility decreased
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 288 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 288 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 288 at risk

Adverse event: Osteitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 288 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 288 at risk

Adverse event: Vertebral foraminal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 288 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 288 at risk

Adverse event: Diffuse large B-cell lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 288 at risk

Adverse event: Gastric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 288 at risk

Adverse event: Metastases to liver
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 288 at risk

Adverse event: Papillary thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 288 at risk

Adverse event: Parathyroid tumour benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 288 at risk

Adverse event: Post transplant lymphoproliferative disorder
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 288 at risk

Adverse event: Central nervous system haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 288 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 288 at risk

Adverse event: Hypertensive encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 288 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 288 at risk

Adverse event: Posterior reversible encephalopathy syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 288 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 288 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 288 at risk

Adverse event: Alcohol withdrawal syndrome
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 288 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 288 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 26 affected / 288 at risk

Adverse event: Azotaemia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 288 at risk

Adverse event: Focal segmental glomerulosclerosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 288 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 288 at risk

Adverse event: Haemorrhage urinary tract
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 288 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 288 at risk

Adverse event: Perinephric collection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 288 at risk

Adverse event: Renal artery stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 288 at risk

Adverse event: Renal artery thrombosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 288 at risk

Adverse event: Renal pain
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 288 at risk

Adverse event: Renal tubular necrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 288 at risk

Adverse event: Ureteric obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 288 at risk

Adverse event: Ureteric stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 288 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 288 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 288 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 288 at risk

Adverse event: Dyspnoea exertional
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 288 at risk

Adverse event: Nasal necrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 288 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 288 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 288 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 288 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 288 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 288 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 288 at risk

Adverse event: Swelling face
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 288 at risk

Adverse event: Therapy change
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 288 at risk

Adverse event: Arteriosclerosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 288 at risk

Adverse event: Axillary vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 288 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 288 at risk

Adverse event: Extremity necrosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 288 at risk

Adverse event: Extrinsic iliac vein compression
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 288 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 288 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 288 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 288 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 288 at risk

Adverse event: Lymphocele
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 288 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 288 at risk

Adverse event: Steal syndrome
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 288 at risk

Adverse event: Subclavian vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 288 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 42 affected / 288 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 288 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 66 affected / 288 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 288 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 288 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 27 affected / 288 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 288 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 288 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 90 affected / 288 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 128 affected / 288 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 288 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 288 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 101 affected / 288 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 288 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 21 affected / 288 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 15 affected / 288 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 45 affected / 288 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 10 affected / 288 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 53 affected / 288 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 28 affected / 288 at risk

Adverse event: BK virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 45 affected / 288 at risk

Adverse event: Cytomegalovirus viraemia
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 288 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 288 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 288 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 50 affected / 288 at risk

Adverse event: Delayed graft function
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 15 affected / 288 at risk

Adverse event: Incision site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 24 affected / 288 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 55 affected / 288 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 37 affected / 288 at risk

Adverse event: Viral test positive
Serious: no
Organ System: Investigations
Frequency: 10 affected / 288 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 16 affected / 288 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 288 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 288 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 288 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 288 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 37 affected / 288 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 81 affected / 288 at risk

Adverse event: Hyperphosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 288 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 37 affected / 288 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 288 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 38 affected / 288 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 124 affected / 288 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 288 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 122 affected / 288 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 50 affected / 288 at risk

Adverse event: Vitamin D deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 38 affected / 288 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 288 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 288 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 288 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 288 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 34 affected / 288 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 46 affected / 288 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 94 affected / 288 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 288 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 40 affected / 288 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 27 affected / 288 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 25 affected / 288 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 288 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 13 affected / 288 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 288 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 32 affected / 288 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 288 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 288 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 288 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 53 affected / 288 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 41 affected / 288 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 288 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 287 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 287 at risk

Adverse event: Blood loss anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 287 at risk

Adverse event: Methaemoglobinaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 287 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 287 at risk

Adverse event: Thrombotic microangiopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 287 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 287 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 287 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 287 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 287 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 287 at risk

Adverse event: Congenital cystic kidney disease
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 287 at risk

Adverse event: Vertigo positional
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 287 at risk

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 287 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 287 at risk

Adverse event: Abdominal pain lower
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 287 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 287 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 287 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 287 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 287 at risk

Adverse event: Gastrointestinal necrosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 287 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 287 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 287 at risk

Adverse event: Intra-abdominal fluid collection
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 287 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 287 at risk

Adverse event: Melaena
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 287 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 287 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 287 at risk

Adverse event: Retroperitoneal haematoma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 287 at risk

Adverse event: Retroperitoneal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 287 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 287 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 287 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 287 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 287 at risk

Adverse event: Incarcerated hernia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 287 at risk

Adverse event: Malaise
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 287 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 287 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 287 at risk

Adverse event: Acute cholecystitis necrotic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 287 at risk

Adverse event: Kidney transplant rejection
Serious: yes
Organ System: Immune system disorders
Frequency: 14 affected / 287 at risk

Adverse event: Renal transplant failure
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 287 at risk

Adverse event: Transplant rejection
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 287 at risk

Adverse event: Abdominal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Abscess neck
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Arteriovenous fistula site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 287 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 287 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Clostridium difficile infection
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 287 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 287 at risk

Adverse event: Cytomegalovirus colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Cytomegalovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 287 at risk

Adverse event: Cytomegalovirus viraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 287 at risk

Adverse event: Disseminated cytomegaloviral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Enterococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Escherichia bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Escherichia infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Escherichia urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 287 at risk

Adverse event: Fungaemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 287 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 287 at risk

Adverse event: Gastroenteritis norovirus
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 287 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Incision site abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 287 at risk

Adverse event: Infected cyst
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Klebsiella bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Lower respiratory tract infection bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Lymph node tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 287 at risk

Adverse event: Perirectal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 287 at risk

Adverse event: Polyomavirus-associated nephropathy
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Pseudomonal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 287 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 287 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 287 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 287 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Staphylococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 287 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 287 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 287 at risk

Adverse event: Urinary tract infection bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 287 at risk

Adverse event: Urinary tract infection enterococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 287 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Vulval abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Vulval cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 287 at risk

Adverse event: Abdominal wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 287 at risk

Adverse event: Animal bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 287 at risk

Adverse event: Complications of transplanted kidney
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 287 at risk

Adverse event: Delayed graft function
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 287 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 287 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 287 at risk

Adverse event: Forearm fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 287 at risk

Adverse event: Subcapsular renal haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 287 at risk

Adverse event: Procedural pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 287 at risk

Adverse event: Psychosis postoperative
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 287 at risk

Adverse event: Seroma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 287 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 287 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 287 at risk

Adverse event: Transplant dysfunction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 287 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 287 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 287 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 287 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 287 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Frequency: 8 affected / 287 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 287 at risk

Adverse event: Immunosuppressant drug level increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 287 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 287 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 287 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 287 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 287 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 287 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 287 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 287 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 287 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 287 at risk

Adverse event: Hypovolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 287 at risk

Adverse event: Lactic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 287 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 287 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 287 at risk

Adverse event: Cervical spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 287 at risk

Adverse event: Muscle haemorrhage
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 287 at risk

Adverse event: Cholangiocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 287 at risk

Adverse event: Malignant ascites
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 287 at risk

Adverse event: Renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 287 at risk

Adverse event: Carotid artery occlusion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 287 at risk

Adverse event: Central nervous system lesion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 287 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 287 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 287 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 287 at risk

Adverse event: Metabolic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 287 at risk

Adverse event: Myelopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 287 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 287 at risk

Adverse event: Status epilepticus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 287 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 287 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 287 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 287 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 31 affected / 287 at risk

Adverse event: Bladder outlet obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 287 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 287 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 287 at risk

Adverse event: Perinephric collection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 287 at risk

Adverse event: Renal artery stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 287 at risk

Adverse event: Renal tubular injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 287 at risk

Adverse event: Renal tubular necrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 287 at risk

Adverse event: Renal vein thrombosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 287 at risk

Adverse event: Tubulointerstitial nephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 287 at risk

Adverse event: Ureteric stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 287 at risk

Adverse event: Urinoma
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 287 at risk

Adverse event: Acquired phimosis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 287 at risk

Adverse event: Scrotal oedema
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 287 at risk

Adverse event: Testicular swelling
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 287 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 287 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 287 at risk

Adverse event: Dyspnoea exertional
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 287 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 287 at risk

Adverse event: Pulmonary infarction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 287 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 287 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 287 at risk

Adverse event: Tachypnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 287 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 287 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 287 at risk

Adverse event: Skin necrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 287 at risk

Adverse event: Arteriovenous fistula
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 287 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 287 at risk

Adverse event: Extremity necrosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 287 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 287 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 287 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 287 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 287 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 287 at risk

Adverse event: Ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 287 at risk

Adverse event: Lymphocele
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 287 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 287 at risk

Adverse event: Steal syndrome
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 287 at risk

Adverse event: Superficial vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 287 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 37 affected / 287 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 21 affected / 287 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 58 affected / 287 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 28 affected / 287 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 287 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 24 affected / 287 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 287 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 287 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 100 affected / 287 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 115 affected / 287 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 287 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 287 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 104 affected / 287 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 61 affected / 287 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 14 affected / 287 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 287 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 45 affected / 287 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 17 affected / 287 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 53 affected / 287 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 38 affected / 287 at risk

Adverse event: BK virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 37 affected / 287 at risk

Adverse event: Cytomegalovirus viraemia
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 287 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 287 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 287 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 44 affected / 287 at risk

Adverse event: Delayed graft function
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 30 affected / 287 at risk

Adverse event: Incision site pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 47 affected / 287 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 91 affected / 287 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 43 affected / 287 at risk

Adverse event: Viral test positive
Serious: no
Organ System: Investigations
Frequency: 18 affected / 287 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 14 affected / 287 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 287 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 287 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 287 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 287 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 58 affected / 287 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 79 affected / 287 at risk

Adverse event: Hyperphosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 287 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 41 affected / 287 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 287 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 37 affected / 287 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 124 affected / 287 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 287 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 122 affected / 287 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 60 affected / 287 at risk

Adverse event: Vitamin D deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 35 affected / 287 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 287 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 287 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 287 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 23 affected / 287 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 30 affected / 287 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 38 affected / 287 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 84 affected / 287 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 24 affected / 287 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 44 affected / 287 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 21 affected / 287 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 30 affected / 287 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 15 affected / 287 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 18 affected / 287 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 287 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 287 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 287 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 287 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 287 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 50 affected / 287 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 45 affected / 287 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 19 affected / 287 at risk