Study: NCT03888066

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 439 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 439 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 439 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 439 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 439 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 439 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 439 at risk

Adverse event: Acute left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 439 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 439 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 439 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 439 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 439 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 439 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 439 at risk

Adverse event: Left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 439 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 439 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 439 at risk

Adverse event: Ventricular extrasystoles
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 439 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 439 at risk

Adverse event: Cardiac failure chronic
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 439 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 439 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 439 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 439 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 439 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 439 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 439 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 439 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 439 at risk

Adverse event: Intestinal pseudo-obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 439 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 439 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 439 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 439 at risk

Adverse event: Calculus urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 439 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 439 at risk

Adverse event: Muscle atrophy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 439 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 439 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 439 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 439 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 439 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 439 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 439 at risk

Adverse event: COVID-19 pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 439 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 439 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 439 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 439 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 439 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 439 at risk

Adverse event: Gynaecomastia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 439 at risk

Adverse event: Glomerular filtration rate decreased
Serious: no
Organ System: Investigations
Frequency: 15 affected / 439 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 439 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 439 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 439 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 439 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 439 at risk

Adverse event: Hydrothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 439 at risk

Adverse event: Acute respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 439 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 439 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 439 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 439 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 439 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 439 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 439 at risk

Adverse event: Renal impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 439 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 439 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 439 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 197 affected / 439 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 66 affected / 439 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 439 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 439 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 439 at risk

Adverse event: Iron deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 439 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 439 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 439 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 439 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 439 at risk

Adverse event: Pancoast's tumour
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 439 at risk

Adverse event: Plasmacytoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 439 at risk

Adverse event: Thyroid neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 439 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 439 at risk

Adverse event: Traumatic intracranial haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 439 at risk

Adverse event: Vascular procedure complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 439 at risk

Adverse event: Ultrasound pancreas abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 439 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 439 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 439 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 439 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 439 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 439 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 439 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 439 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 439 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 439 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 439 at risk

Adverse event: Pulseless electrical activity
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 439 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 439 at risk

Adverse event: Cardiac failure chronic
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 439 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 439 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 439 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 439 at risk

Adverse event: Laryngeal dyskinesia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 439 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 439 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 439 at risk

Adverse event: Brain injury
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 439 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 439 at risk

Adverse event: Status epilepticus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 439 at risk

Adverse event: Vascular encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 439 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 439 at risk

Adverse event: Inflammatory bowel disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 439 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 439 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 439 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 439 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 439 at risk

Adverse event: End stage renal disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 439 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 439 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 439 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 439 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 439 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 439 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 439 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 439 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 439 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 439 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 439 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 5 affected / 439 at risk

Adverse event: Glomerular filtration rate decreased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 439 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 439 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 439 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 439 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 439 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 439 at risk

Adverse event: Hydrothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 439 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 439 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 439 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 439 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 439 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 439 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 439 at risk

Adverse event: Renal impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 439 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 439 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 439 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 238 affected / 439 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 47 affected / 439 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 439 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 439 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 439 at risk

Adverse event: Iron deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 439 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 439 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 439 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 439 at risk

Adverse event: Respiratory tract infection viral
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 439 at risk