Study: NCT03584464

Adverse event: Normocytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 205 at risk

Adverse event: Acute left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 205 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 205 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 205 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 205 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 205 at risk

Adverse event: Atrioventricular block second degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 205 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 205 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 205 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 205 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 205 at risk

Adverse event: Coronary artery dissection
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 205 at risk

Adverse event: Sinus arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 205 at risk

Adverse event: Diverticulum intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 205 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 205 at risk

Adverse event: Melaena
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 205 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 205 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 205 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Site reported an unknown cause of death, therefore there is no known event that led to death. The event has been reviewed by our Safety Specialist and was adjudicated.
Frequency: 1 affected / 205 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 205 at risk

Adverse event: Vascular stent stenosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 205 at risk

Adverse event: Vessel puncture site haematoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 205 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 205 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 205 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 205 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 205 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 205 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 205 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 205 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 205 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 205 at risk

Adverse event: Cardiac procedure complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 205 at risk

Adverse event: Postoperative respiratory failure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 205 at risk

Adverse event: Procedural pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 205 at risk

Adverse event: Myocardial necrosis marker increased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 205 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 205 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 205 at risk

Adverse event: Rectal adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 205 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 205 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 205 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 205 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 205 at risk

Adverse event: Unresponsive to stimuli
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 205 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 205 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 205 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 205 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 205 at risk

Adverse event: Carotid endarterectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 205 at risk

Adverse event: Coronary artery bypass
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 205 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 205 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 205 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 205 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 205 at risk

Adverse event: Blood loss anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 205 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 205 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 205 at risk

Adverse event: Bundle branch block left
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 205 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 205 at risk

Adverse event: Coronary artery dissection
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 205 at risk

Adverse event: Coronary artery occlusion
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 205 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 205 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 205 at risk

Adverse event: Gingival bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 205 at risk

Adverse event: Pneumoperitoneum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 205 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 205 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 205 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 205 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 205 at risk

Adverse event: Vascular stent stenosis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 205 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 205 at risk

Adverse event: Cardiac procedure complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 205 at risk

Adverse event: Face injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 205 at risk

Adverse event: Patella fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 205 at risk

Adverse event: Periprocedural myocardial infarction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 205 at risk

Adverse event: Plaque shift
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 205 at risk

Adverse event: Vascular access complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 205 at risk

Adverse event: Vascular access site swelling
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 205 at risk

Adverse event: Inflammatory marker increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 205 at risk

Adverse event: Myocardial necrosis marker increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 205 at risk

Adverse event: Troponin I increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 205 at risk

Adverse event: Troponin increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 205 at risk

Adverse event: Basal cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 205 at risk

Adverse event: Intraductal proliferative breast lesion
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 205 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 205 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 205 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 205 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 205 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 205 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 205 at risk

Adverse event: Labile hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 205 at risk