Study: NCT04679935

Adverse event: Eye inflammation- Study Eye
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: Endophthalmitis- Study Eye
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Chromophobe renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 25 at risk

Adverse event: Hepatic neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 25 at risk

Adverse event: Ballismus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Anterior chamber cell- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: Chalazion- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: Conjunctival haemorrhage- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 25 at risk

Adverse event: Conjunctival irritation- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: Corneal erosion- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: Dry eye- Bilateral
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: Eye irritation- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: Macular oedema- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: Neovascular age-related macular degeneration- Fellow Eye
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 25 at risk

Adverse event: Neovascular age-related macular degeneration- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: Ocular hyperaemia- Fellow Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: Retinal haemorrhage- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: Retinal oedema- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: Retinopathy hypertensive
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: Subretinal fluid- Fellow Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: Subretinal fluid- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: Visual acuity reduced- Bilateral
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: Visual acuity reduced- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: Vitreous detachment- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 25 at risk

Adverse event: Vitreous haemorrhage- Fellow Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 25 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 25 at risk

Adverse event: Arthritis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 25 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Gastrointestinal viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Hordeolum- Study Eye
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Lyme disease
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 25 at risk

Adverse event: Sialoadenitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Arthropod sting
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 25 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 25 at risk

Adverse event: Epicondylitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 25 at risk

Adverse event: Expired product administered- Study Eye
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 25 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 25 at risk

Adverse event: Intra-ocular injection complication- Study Eye
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 25 at risk

Adverse event: Rib fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 25 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 25 at risk

Adverse event: Stress fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 25 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 25 at risk

Adverse event: Intraocular pressure increased- Study Eye
Serious: no
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: Vital dye staining cornea present- Study Eye
Serious: no
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: Glucose tolerance impaired
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 25 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 25 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Intervertebral disc protrusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 25 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Restless legs syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Benign prostatic hyperplasia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 25 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Palmar erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 25 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 25 at risk

Adverse event: Hypertensive crisis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 25 at risk

Adverse event: Eye inflammation- Study Eye
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Iridocyclitis- Study Eye
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Retinal haemorrhage- Study Eye
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Retinal neovascularisation- Study Eye
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Retinal vasculitis- Study Eye
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Visual acuity reduced- Study Eye
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Colitis ischaemic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Diverticulum intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Kidney infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Intraocular pressure increased- Study Eye
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 27 at risk

Adverse event: Blepharitis- Bilateral
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Cataract- Bilateral
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Cataract- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Conjunctival haemorrhage- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 27 at risk

Adverse event: Conjunctival hyperaemia- Fellow Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Conjunctivitis allergic- Bilateral
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 27 at risk

Adverse event: Corneal epithelial microcysts- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Detachment of retinal pigment epithelium- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Dry eye- Bilateral
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 27 at risk

Adverse event: Eczema eyelids- Fellow Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Eczema eyelids- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Episcleritis- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Eye inflammation- Bilateral
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Eye inflammation- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 27 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Eye pain- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Eye ulcer- Fellow Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Foreign body sensation in eyes- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Macular oedema- Fellow Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Macular oedema- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Neovascular age-related macular degeneration- Fellow Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Neovascular age-related macular degeneration- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 27 at risk

Adverse event: Posterior capsule opacification- Fellow Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Retinal aneurysm- Fellow Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Retinal aneurysm- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Retinal cyst- Fellow Eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 27 at risk

Adverse event: Retinal exudates- Bilateral
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Retinal exudates- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Retinal haemorrhage- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Retinal oedema- Fellow Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Retinal oedema- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 27 at risk

Adverse event: Retinal vasculitis- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 27 at risk

Adverse event: Scleritis- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Subretinal fibrosis- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Subretinal fluid- Fellow Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Subretinal fluid- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Vision blurred- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Visual acuity reduced- Fellow Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Visual acuity reduced- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 27 at risk

Adverse event: Vitreal cells- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Vitreous detachment- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Vitreous floaters- Bilateral
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Vitreous floaters- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 27 at risk

Adverse event: Vitreous opacities- Study Eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 27 at risk

Adverse event: Tooth impacted
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Application site wound
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Injection site pain- Study Eye
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Retention cyst- Fellow Eye
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 27 at risk

Adverse event: Conjunctivitis- Study Eye
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 27 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 27 at risk

Adverse event: Herpes virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 27 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Bone contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 27 at risk

Adverse event: Expired product administered- Study Eye
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 27 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 27 at risk

Adverse event: Intra-ocular injection complication- Fellow Eye
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 27 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 27 at risk

Adverse event: Meniscus injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 27 at risk

Adverse event: Intraocular pressure increased- Fellow Eye
Serious: no
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Intraocular pressure increased- Study Eye
Serious: no
Organ System: Investigations
Frequency: 2 affected / 27 at risk

Adverse event: Vital dye staining cornea present- Study Eye
Serious: no
Organ System: Investigations
Frequency: 1 affected / 27 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Jaw cyst
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Muscle tightness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Synovial cyst
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Basal cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 27 at risk

Adverse event: Blepharal papilloma- Fellow Eye
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 27 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 27 at risk

Adverse event: Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 27 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 27 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 27 at risk

Adverse event: Thrombophlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 27 at risk