Study: NCT04239027

Adverse event: Aortic valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Eye haematoma - Fellow eye
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Iridocyclitis - Study eye
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Uveitis - Study eye
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 210 at risk

Adverse event: Vitritis - Study eye
Serious: yes
Organ System: Eye disorders
Frequency: 4 affected / 210 at risk

Adverse event: Autoimmune pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 210 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 210 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 210 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: Bladder transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 210 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 210 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 210 at risk

Adverse event: Aortic dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 210 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 210 at risk

Adverse event: Peripheral artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 210 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 210 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Arteriosclerosis coronary artery
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 210 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 210 at risk

Adverse event: Age-related macular degeneration - Fellow eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Anterior chamber cell - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Anterior chamber inflammation - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 210 at risk

Adverse event: Blepharitis - Both eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 210 at risk

Adverse event: Cataract - Both eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 210 at risk

Adverse event: Cataract - Fellow eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 210 at risk

Adverse event: Cataract - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 210 at risk

Adverse event: Chalazion
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 210 at risk

Adverse event: Conjunctival haemorrhage - Both eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Conjunctival haemorrhage - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 210 at risk

Adverse event: Conjunctivitis allergic - Both eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Detachment of macular retinal pigment epithelium - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Detachment of retinal pigment epithelium - Fellow eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Diplopia - Both eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Dry eye - Both eye
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 210 at risk

Adverse event: Dry eye - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 210 at risk

Adverse event: Eye inflammation - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Eye irritation - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Eye pain - Both eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 210 at risk

Adverse event: Eye pain - Fellow eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Eye pain - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 210 at risk

Adverse event: Eye pruritus - Both eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Eye pruritus - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 210 at risk

Adverse event: Eyelid ptosis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Eyelids pruritus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Foreign body sensation in eyes - Both eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Foreign body sensation in eyes - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Iridocyclitis - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 210 at risk

Adverse event: Keratitis - Both eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 210 at risk

Adverse event: Keratitis - Fellow eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 210 at risk

Adverse event: Keratitis - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 210 at risk

Adverse event: Lacrimation increased - Both eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Lacrimation increased - Fellow eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Lacrimation increased - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 210 at risk

Adverse event: Metamorphopsia - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 210 at risk

Adverse event: Neovascular age-related macular degeneration - Fellow eye
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 210 at risk

Adverse event: Ocular discomfort - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 210 at risk

Adverse event: Ocular hyperaemia - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Ocular hypertension - Both eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Ocular hypertension - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 210 at risk

Adverse event: Ocular vasculitis - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 210 at risk

Adverse event: Periorbital pain - Both eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Photophobia - Both eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Photophobia - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Photopsia - Both eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Posterior capsule opacification - Both eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Posterior capsule opacification - Fellow eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Punctate keratitis - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 210 at risk

Adverse event: Retinal cyst - Fellow eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Retinal degeneration - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 210 at risk

Adverse event: Retinal fibrosis - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Retinal haemorrhage - Both eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 210 at risk

Adverse event: Retinal haemorrhage - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 210 at risk

Adverse event: Retinal neovascularisation - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Retinal occlusive vasculitis - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 210 at risk

Adverse event: Retinal oedema - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Retinal perivascular sheathing - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Retinal pigment epithelial tear - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 210 at risk

Adverse event: Retinal vasculitis - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 210 at risk

Adverse event: Serous retinal detachment - Fellow eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 210 at risk

Adverse event: Serous retinal detachment - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 210 at risk

Adverse event: Swelling of eyelid
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Uveitis - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 210 at risk

Adverse event: Vision blurred - Both eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Vision blurred - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 210 at risk

Adverse event: Visual acuity reduced - Both eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Visual acuity reduced - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 210 at risk

Adverse event: Visual field defect - Fellow eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Visual field defect - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 210 at risk

Adverse event: Vitreoretinal traction syndrome - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Vitreous detachment - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 210 at risk

Adverse event: Vitreous floaters - Both eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Vitreous floaters - Fellow eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 210 at risk

Adverse event: Vitreous floaters - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 210 at risk

Adverse event: Vitreous haze - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 210 at risk

Adverse event: Vitritis - Study eye
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 210 at risk

Adverse event: Aerophagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 210 at risk

Adverse event: Dental cyst
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 210 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 210 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 210 at risk

Adverse event: Cholestasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 210 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 210 at risk

Adverse event: Drug hypersensitivity - Both eye
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 210 at risk

Adverse event: Seasonal allergy - Both eye
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 210 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 210 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 210 at risk

Adverse event: Conjunctivitis - Fellow eye
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 210 at risk

Adverse event: Conjunctivitis - Study eye
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 210 at risk

Adverse event: Conjunctivitis viral - Fellow eye
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 210 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 210 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 210 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 210 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 210 at risk

Adverse event: Tracheitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 210 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 210 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 210 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 210 at risk

Adverse event: Foreign body in eye - Study eye
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 210 at risk

Adverse event: Hand fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 210 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 210 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 210 at risk

Adverse event: Lip injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 210 at risk

Adverse event: Postoperative hypertension - Study eye
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 210 at risk

Adverse event: Procedural pain - Study eye
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 210 at risk

Adverse event: Radius fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 210 at risk

Adverse event: Skeletal injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 210 at risk

Adverse event: Wrist fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 210 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 210 at risk

Adverse event: Intraocular pressure increased - Study eye
Serious: no
Organ System: Investigations
Frequency: 1 affected / 210 at risk

Adverse event: SARS-CoV-2 test positive
Serious: no
Organ System: Investigations
Frequency: 2 affected / 210 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 210 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 210 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 210 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 210 at risk

Adverse event: Vitamin B12 deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 210 at risk

Adverse event: Vitamin D deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 210 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 210 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 210 at risk

Adverse event: Intervertebral disc protrusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: Rheumatic disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: Rheumatoid arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: Ear neoplasm malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 210 at risk

Adverse event: Balance disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 210 at risk

Adverse event: Cerebral ischaemia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 210 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 210 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 210 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 210 at risk

Adverse event: Ischaemic stroke
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 210 at risk

Adverse event: Leukoencephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 210 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 210 at risk

Adverse event: Retinal migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 210 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 210 at risk

Adverse event: White matter lesion
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 210 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 210 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 210 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 210 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 210 at risk

Adverse event: Pulmonary mass
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Sinus pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 210 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: Skin disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 210 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 210 at risk