Study: NCT03605667

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 178 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 178 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 178 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 178 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 178 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 178 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 178 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 178 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 178 at risk

Adverse event: Hypothermia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 178 at risk

Adverse event: Pelvic mass
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 178 at risk

Adverse event: Hepatic lesion
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 178 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 178 at risk

Adverse event: Colonic abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 178 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 178 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 178 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 178 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 178 at risk

Adverse event: Craniofacial fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 178 at risk

Adverse event: Frostbite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 178 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 178 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 178 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 178 at risk

Adverse event: Non-small cell lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 178 at risk

Adverse event: Lacunar infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 178 at risk

Adverse event: Neuropsychological symptoms
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 178 at risk

Adverse event: Aggression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 178 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 178 at risk

Adverse event: Paranoia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 178 at risk

Adverse event: Somnambulism
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 178 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 178 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 178 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 178 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 178 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 178 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 9 affected / 178 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 178 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 19 affected / 178 at risk

Adverse event: Liver function test increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 178 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 16 affected / 178 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 178 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 178 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 178 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 178 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 171 at risk

Adverse event: Diverticulum intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 171 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 171 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 171 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 171 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 171 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 171 at risk

Adverse event: Craniofacial fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 171 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 171 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 171 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 171 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 171 at risk

Adverse event: Embolic cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 171 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 171 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 171 at risk

Adverse event: Agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 171 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 171 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 171 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 171 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 171 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 171 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 171 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 171 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 171 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 171 at risk

Adverse event: Faecaloma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Colonic abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Coronavirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 90 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 90 at risk

Adverse event: Pelvic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 90 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 90 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 90 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Coronavirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 90 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 90 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 90 at risk

Adverse event: Liver function test increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 90 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 90 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 90 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 90 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 90 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 103 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 103 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 103 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 103 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Duodenal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 103 at risk

Adverse event: COVID-19 pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 103 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 103 at risk

Adverse event: Leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 103 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 103 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 103 at risk

Adverse event: Agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 103 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 103 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 103 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 103 at risk

Adverse event: Coronavirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 103 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 103 at risk

Adverse event: Liver function test increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 103 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 103 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 103 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 103 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 103 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 103 at risk