Study: NCT03136484

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 392 at risk

Adverse event: Airway complication of anaesthesia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 392 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 392 at risk

Adverse event: Arteriosclerosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 392 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 392 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 392 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 392 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 392 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 392 at risk

Adverse event: Glomerular filtration rate decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 392 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 392 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 392 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 392 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 392 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 392 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 392 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 392 at risk

Adverse event: Patella fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 392 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 392 at risk

Adverse event: Post procedural haematuria
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 392 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 392 at risk

Adverse event: Retinal infarction
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 392 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 392 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 392 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 392 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 392 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 392 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 392 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 26 affected / 392 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 59 affected / 392 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 392 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 392 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 392 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 89 affected / 392 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 50 affected / 392 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 394 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 394 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 394 at risk

Adverse event: Bartholin's cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 394 at risk

Adverse event: Basal ganglia haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 394 at risk

Adverse event: Bipolar disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 394 at risk

Adverse event: Cellulitis gangrenous
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 394 at risk

Adverse event: Cellulitis staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 394 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 394 at risk

Adverse event: Cholecystitis chronic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 394 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 394 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 394 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 394 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 394 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 394 at risk

Adverse event: Haemorrhoids thrombosed
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 394 at risk

Adverse event: Hepatic cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 394 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 394 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 394 at risk

Adverse event: Perirectal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 394 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 394 at risk

Adverse event: Prescribed overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 394 at risk

Adverse event: Prostate cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 394 at risk

Adverse event: Prostatism
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 394 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 394 at risk

Adverse event: Respiratory tract infection viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 394 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 394 at risk

Adverse event: Splenomegaly
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 394 at risk

Adverse event: Transaminases increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 394 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 394 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 394 at risk

Adverse event: Vulval abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 394 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 394 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 394 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 394 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 394 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 394 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 394 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 394 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 394 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 394 at risk