Study: NCT05133180

Adverse event: Visual acuity reduced
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 52 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Hypertransaminasaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 52 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Asthenopia - Mild
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 52 at risk

Adverse event: Chalazion - Mild
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 52 at risk

Adverse event: Chalazion - Moderate
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 52 at risk

Adverse event: Conjunctival hyperaemia - Mild
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 52 at risk

Adverse event: Corneal oedema - Moderate
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 52 at risk

Adverse event: Dry eye - Mild
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 52 at risk

Adverse event: Dry eye - Moderate
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 52 at risk

Adverse event: Eye discharge - Mild
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 52 at risk

Adverse event: Eye irritation - Mild
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 52 at risk

Adverse event: Eye irritation - Moderate
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 52 at risk

Adverse event: Eye pain - Mild
Serious: no
Organ System: Eye disorders
Frequency: 16 affected / 52 at risk

Adverse event: Eye pain - Moderate
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 52 at risk

Adverse event: Eye pain - Severe
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 52 at risk

Adverse event: Eye pruritus - Mild
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 52 at risk

Adverse event: Eyelid disorder - Mild
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 52 at risk

Adverse event: Eyelid pain - Mild
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 52 at risk

Adverse event: Eyelid pain - Moderate
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 52 at risk

Adverse event: Eyelid pain - Severe
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 52 at risk

Adverse event: Eyelid ptosis - Moderate
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 52 at risk

Adverse event: Eyelid sensory disorder - Mild
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 52 at risk

Adverse event: Foreign body sensation in eyes - Moderate
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 52 at risk

Adverse event: Keratopathy - Moderate
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 52 at risk

Adverse event: Lacrimation increased - Mild
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 52 at risk

Adverse event: Ocular hyperaemia - Mild
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 52 at risk

Adverse event: Periorbital pain - Mild
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 52 at risk

Adverse event: Periorbital pain - Moderate
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 52 at risk

Adverse event: Photophobia - Mild
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 52 at risk

Adverse event: Photophobia - Moderate
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 52 at risk

Adverse event: Photophobia - Severe
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 52 at risk

Adverse event: Punctate keratitis - Moderate
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 52 at risk

Adverse event: Swelling of eyelid - Moderate
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 52 at risk

Adverse event: Ulcerative keratitis - Mild
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 52 at risk

Adverse event: Vision blurred - Mild
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 52 at risk

Adverse event: Vision blurred - Moderate
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 52 at risk

Adverse event: Visual acuity reduced - Moderate
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 52 at risk

Adverse event: Visual field defect - Mild
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 52 at risk

Adverse event: Visual impairment - Moderate
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 52 at risk

Adverse event: Pancreatitis acute - Moderate
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Fatigue - Severe
Serious: no
Organ System: General disorders
Frequency: 1 affected / 52 at risk

Adverse event: Instillation site pain - Mild
Serious: no
Organ System: General disorders
Frequency: 1 affected / 52 at risk

Adverse event: Bile duct stone - Moderate
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 52 at risk

Adverse event: Hypertransaminasaemia - Moderate
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 52 at risk

Adverse event: Bacteraemia - Moderate
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: COVID-19 - Mild
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: COVID-19 - Moderate
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Genital herpes simplex -Mild
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Upper respiratory tract infection - Mild
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Urinary tract infection - Mild
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Arthropod bite - Mild
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 52 at risk

Adverse event: Meniscus injury - Moderate
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 52 at risk

Adverse event: Spinal compression fracture - Mild
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 52 at risk

Adverse event: Blood thyroid stimulating hormone increased - Mild
Serious: no
Organ System: Investigations
Frequency: 1 affected / 52 at risk

Adverse event: Fibromyalgia - Moderate
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: Rheumatoid arthritis - Mild
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: Scleroderma - Moderate
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: Systemic lupus erythematosus - Moderate
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: Aura - Mild
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Headache - Mild
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Headache - Moderate
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Headache - Severe
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Migraine - Mild
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Arthropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 51 at risk

Adverse event: Anaemia - Mild
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 51 at risk

Adverse event: Deafness bilateral - Mild
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 51 at risk

Adverse event: Vertigo positional - Moderate
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 51 at risk

Adverse event: Asthenopia - Mild
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Corneal epithelium defect - Mild
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Dry eye - Moderate
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Erythema of eyelid - Mild
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Eye discharge - Mild
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Eye discharge - Moderate
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Eye inflammation - Moderate
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Eye irritation - Mild
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Eye irritation - Moderate
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 51 at risk

Adverse event: Eye pain - Mild
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 51 at risk

Adverse event: Eye pain - Moderate
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 51 at risk

Adverse event: Eye pruritus - Mild
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 51 at risk

Adverse event: Eye pruritus - Moderate
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 51 at risk

Adverse event: Eyelid margin crusting - Mild
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Foreign body sensation in eyes - Mild
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Foreign body sensation in eyes - Moderate
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 51 at risk

Adverse event: Ocular hyperaemia - Mild
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 51 at risk

Adverse event: Photophobia - Mild
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Photophobia - Moderate
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Photophobia - Severe
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Vision blurred - Mild
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Vision blurred - Moderate
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Visual impairment - Moderate
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Seasonal allergy - Moderate
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 51 at risk

Adverse event: COVID-19 - Mild
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Coronavirus infection - Mild
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Otitis media - Mild
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Sinusitis - Mild
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Upper respiratory tract infection - Mild
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Urinary tract infection - Mild
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Skin laceration - Moderate
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 51 at risk

Adverse event: Arthralgia - Moderate
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 51 at risk

Adverse event: Arthropathy - Severe
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 51 at risk

Adverse event: Back pain - Mild
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 51 at risk

Adverse event: Pain in jaw - Moderate
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 51 at risk

Adverse event: Sjogren's syndrome - Moderate
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 51 at risk

Adverse event: Headache - Mild
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 51 at risk

Adverse event: Headache - Moderate
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 51 at risk