Study: NCT04740931

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 365 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 365 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the fellow eye
Frequency: 1 affected / 365 at risk

Adverse event: Cystoid macular oedema
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 2 affected / 365 at risk

Adverse event: Macular ischaemia
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 1 affected / 365 at risk

Adverse event: Retinal artery occlusion
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 2 affected / 365 at risk

Adverse event: Retinal ischaemia
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 1 affected / 365 at risk

Adverse event: Retinal vein occlusion
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 2 affected / 365 at risk

Adverse event: Rhegmatogenous retinal detachment
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 1 affected / 365 at risk

Adverse event: Uveitis
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 2 affected / 365 at risk

Adverse event: Vitreous haemorrhage
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 1 affected / 365 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 365 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 365 at risk

Adverse event: Osteomyelitis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 365 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 365 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 365 at risk

Adverse event: Eye injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: AEs occurred in the study eye
Frequency: 1 affected / 365 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 365 at risk

Adverse event: Type 2 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 365 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 365 at risk

Adverse event: Lumbar spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 365 at risk

Adverse event: Gastric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 365 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 365 at risk

Adverse event: Peripheral sensorimotor neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 365 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 365 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 365 at risk

Adverse event: Uterine haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 365 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 365 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 365 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 365 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 10 affected / 365 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 11 affected / 365 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 365 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Notes: AEs occurred in the study eye
Frequency: 9 affected / 365 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 365 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 3 affected / 365 at risk

Adverse event: Cystoid macular oedema
Serious: no
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 1 affected / 365 at risk

Adverse event: Macular oedema
Serious: no
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 2 affected / 365 at risk

Adverse event: Epiretinal membrane
Serious: no
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 3 affected / 365 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 365 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 361 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 361 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 361 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 361 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 361 at risk

Adverse event: Thyroid mass
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 361 at risk

Adverse event: Cystoid macular oedema
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 2 affected / 361 at risk

Adverse event: Macular oedema
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 1 affected / 361 at risk

Adverse event: Non-infectious endophthalmitis
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 1 affected / 361 at risk

Adverse event: Retinal artery embolism
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 1 affected / 361 at risk

Adverse event: Retinal artery occlusion
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 1 affected / 361 at risk

Adverse event: Retinal ischaemia
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 2 affected / 361 at risk

Adverse event: Retinal tear
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 2 affected / 361 at risk

Adverse event: Retinal vein occlusion
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 2 affected / 361 at risk

Adverse event: Duodenal bulb deformity
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 361 at risk

Adverse event: Duodenitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 361 at risk

Adverse event: Gastritis erosive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 361 at risk

Adverse event: Haematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 361 at risk

Adverse event: Obstructive pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 361 at risk

Adverse event: Peptic ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 361 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 361 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 361 at risk

Adverse event: Gallbladder disorder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 361 at risk

Adverse event: Hepatic steatosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 361 at risk

Adverse event: Endophthalmitis
Serious: yes
Organ System: Infections and infestations
Notes: AEs occurred in the study eye
Frequency: 1 affected / 361 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 361 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 361 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 361 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 361 at risk

Adverse event: Shunt occlusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 361 at risk

Adverse event: Intraocular pressure increased
Serious: yes
Organ System: Investigations
Notes: AEs occurred in the study eye
Frequency: 1 affected / 361 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 361 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 361 at risk

Adverse event: Bladder adenocarcinoma stage unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 361 at risk

Adverse event: Squamous cell carcinoma of the oral cavity
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 361 at risk

Adverse event: Altered state of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 361 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 361 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 361 at risk

Adverse event: Calculus urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 361 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 361 at risk

Adverse event: Urethral stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 361 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 361 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 361 at risk

Adverse event: Pickwickian syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 361 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 361 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 361 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 361 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 361 at risk

Adverse event: Knee operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 361 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 361 at risk

Adverse event: Retinal vein occlusion
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the fellow eye
Frequency: 1 affected / 361 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 361 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 14 affected / 361 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 9 affected / 361 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 361 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Notes: AEs occurred in the study eye
Frequency: 12 affected / 361 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 361 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 7 affected / 361 at risk

Adverse event: Cystoid macular oedema
Serious: no
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 3 affected / 361 at risk

Adverse event: Epiretinal membrane
Serious: no
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 2 affected / 361 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 361 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 359 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 359 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 359 at risk

Adverse event: Cystoid macular oedema
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 5 affected / 359 at risk

Adverse event: Macular ischaemia
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 1 affected / 359 at risk

Adverse event: Macular oedema
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 4 affected / 359 at risk

Adverse event: Retinal artery embolism
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 1 affected / 359 at risk

Adverse event: Retinal ischaemia
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 1 affected / 359 at risk

Adverse event: Retinal tear
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 1 affected / 359 at risk

Adverse event: Retinal vein occlusion
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 5 affected / 359 at risk

Adverse event: Uveitis
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 1 affected / 359 at risk

Adverse event: Visual acuity reduced
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 1 affected / 359 at risk

Adverse event: Vitreous haemorrhage
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 1 affected / 359 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 359 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 359 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 359 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 359 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 359 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 359 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 359 at risk

Adverse event: Stress cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 359 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 359 at risk

Adverse event: Mesenteric lymphadenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 359 at risk

Adverse event: Macular oedema
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the fellow eye
Frequency: 1 affected / 359 at risk

Adverse event: Epiretinal membrane
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 1 affected / 359 at risk

Adverse event: Iridocyclitis
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 1 affected / 359 at risk

Adverse event: Macular hole
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 1 affected / 359 at risk

Adverse event: Posterior capsule opacification
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 1 affected / 359 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 1 affected / 359 at risk

Adverse event: Retinal neovascularisation
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 1 affected / 359 at risk

Adverse event: Vitritis
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 1 affected / 359 at risk

Adverse event: Duodenal ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 359 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 359 at risk

Adverse event: Gastrointestinal inflammation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 359 at risk

Adverse event: Large intestine polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 359 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 359 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 359 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 359 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 359 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 359 at risk

Adverse event: COVID-19 pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 359 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 359 at risk

Adverse event: Clostridium difficile infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 359 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 359 at risk

Adverse event: Necrotising fasciitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 359 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 359 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 359 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 359 at risk

Adverse event: Mobility decreased
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 359 at risk

Adverse event: Polymyositis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 359 at risk

Adverse event: Benign neoplasm of thyroid gland
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 359 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 359 at risk

Adverse event: Papillary thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 359 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 359 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 359 at risk

Adverse event: Diabetic nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 359 at risk

Adverse event: Nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 359 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 359 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 359 at risk

Adverse event: Aortic dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 359 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 359 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 10 affected / 359 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 6 affected / 359 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 42 affected / 359 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Notes: AEs occurred in the study eye
Frequency: 16 affected / 359 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 359 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 14 affected / 359 at risk

Adverse event: Cystoid macular oedema
Serious: no
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 11 affected / 359 at risk

Adverse event: Macular oedema
Serious: no
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 7 affected / 359 at risk

Adverse event: Epiretinal membrane
Serious: no
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 3 affected / 359 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 359 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 342 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 342 at risk

Adverse event: Cystoid macular oedema
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 1 affected / 342 at risk

Adverse event: Retinal artery occlusion
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 2 affected / 342 at risk

Adverse event: Retinal ischaemia
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 1 affected / 342 at risk

Adverse event: Retinal vein occlusion
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 3 affected / 342 at risk

Adverse event: Endophthalmitis
Serious: yes
Organ System: Infections and infestations
Notes: AEs occurred in the study eye
Frequency: 1 affected / 342 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 342 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 342 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 342 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 342 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 342 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 342 at risk

Adverse event: Aortic valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 342 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 342 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 342 at risk

Adverse event: Deficiency anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 342 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 1 affected / 342 at risk

Adverse event: Iris neovascularisation
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 1 affected / 342 at risk

Adverse event: Macular hole
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 1 affected / 342 at risk

Adverse event: Retinal neovascularisation
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 1 affected / 342 at risk

Adverse event: Diverticulum intestinal haemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 342 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 342 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 342 at risk

Adverse event: Stent-graft endoleak
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 342 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 342 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 342 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 342 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 342 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 342 at risk

Adverse event: Escherichia urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 342 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 342 at risk

Adverse event: Kidney infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 342 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 342 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 342 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 342 at risk

Adverse event: Tooth infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 342 at risk

Adverse event: Urinary tract candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 342 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 342 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 342 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 342 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 342 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 342 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 342 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 342 at risk

Adverse event: Shunt stenosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 342 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 342 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 342 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 342 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 342 at risk

Adverse event: Joint effusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 342 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 342 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 342 at risk

Adverse event: Thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 342 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 342 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 342 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 342 at risk

Adverse event: Cystitis interstitial
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 342 at risk

Adverse event: End stage renal disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 342 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 342 at risk

Adverse event: Cystocele
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 342 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 342 at risk

Adverse event: Obstructive sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 342 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 342 at risk

Adverse event: Ligament operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 342 at risk

Adverse event: Renal transplant
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 342 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 342 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 342 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 342 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 342 at risk

Adverse event: Peripheral artery aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 342 at risk

Adverse event: Secondary hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 342 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 1 affected / 342 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 7 affected / 342 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 14 affected / 342 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 46 affected / 342 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Notes: AEs occurred in the study eye
Frequency: 15 affected / 342 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 342 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 14 affected / 342 at risk

Adverse event: Cystoid macular oedema
Serious: no
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 10 affected / 342 at risk

Adverse event: Macular oedema
Serious: no
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 14 affected / 342 at risk

Adverse event: Epiretinal membrane
Serious: no
Organ System: Eye disorders
Notes: AEs occurred in the study eye
Frequency: 11 affected / 342 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 342 at risk