Study: NCT03557307

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 598 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 598 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 598 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 598 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 598 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 598 at risk

Adverse event: Ventricular extrasystoles
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 598 at risk

Adverse event: Meniere's disease
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 598 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Anal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 598 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Sudden cardiac death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 598 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 598 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 598 at risk

Adverse event: Chronic sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 598 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 598 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 598 at risk

Adverse event: H1N1 influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 598 at risk

Adverse event: Haemophilus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 598 at risk

Adverse event: Infected bite
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 598 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 598 at risk

Adverse event: Lower respiratory tract infection bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 598 at risk

Adverse event: Pelvic abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 598 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 598 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 598 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 598 at risk

Adverse event: Pneumonia haemophilus
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 598 at risk

Adverse event: Pneumonia influenzal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 598 at risk

Adverse event: Pneumonia pseudomonal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 598 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 598 at risk

Adverse event: Respiratory tract infection bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 598 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 598 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 598 at risk

Adverse event: Alcohol poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 598 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 598 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 598 at risk

Adverse event: Multiple fractures
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 598 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 598 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 598 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 598 at risk

Adverse event: Tendon rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 598 at risk

Adverse event: Oxygen saturation decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 598 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 598 at risk

Adverse event: Type 2 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 598 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 598 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 598 at risk

Adverse event: Polymyalgia rheumatica
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 598 at risk

Adverse event: Adenocarcinoma of colon
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 598 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 598 at risk

Adverse event: Malignant glioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 598 at risk

Adverse event: Neurofibroma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 598 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 598 at risk

Adverse event: Apallic syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 598 at risk

Adverse event: Carotid artery aneurysm
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 598 at risk

Adverse event: Dizziness postural
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 598 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 598 at risk

Adverse event: Sciatica
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 598 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 598 at risk

Adverse event: Breast calcifications
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 598 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: NSAID exacerbated respiratory disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 598 at risk

Adverse event: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Chronic rhinosinusitis with nasal polyps
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Pharyngeal swelling
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 598 at risk

Adverse event: Embolism arterial
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 598 at risk

Adverse event: Hypertensive emergency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 598 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 33 affected / 598 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 64 affected / 598 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 598 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 598 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 598 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 29 affected / 598 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 21 affected / 598 at risk