Study: NCT03691649

Adverse event: Cystoid macular
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 211 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 211 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 211 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 211 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 211 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 211 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 211 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 211 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 211 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 211 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 211 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 211 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 211 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 211 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 211 at risk

Adverse event: Growth of eyelashes
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 211 at risk

Adverse event: Instillation site pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 211 at risk

Adverse event: Vital dye staining cornea present
Serious: no
Organ System: Investigations
Frequency: 7 affected / 211 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 211 at risk

Adverse event: Influenza Type A test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 215 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 215 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 215 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 215 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 215 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 215 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 215 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 215 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 215 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 215 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 215 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 215 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 215 at risk

Adverse event: Growth of eyelashes
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 215 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 215 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 215 at risk

Adverse event: Instillation site pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 215 at risk

Adverse event: Vital dye staining cornea present
Serious: no
Organ System: Investigations
Frequency: 5 affected / 215 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 215 at risk

Adverse event: Cystoid macular
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 377 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 377 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 377 at risk

Adverse event: Acute cardiac event
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 377 at risk

Adverse event: Osteoporosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 377 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 377 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 377 at risk

Adverse event: Uterine cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 377 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 377 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 377 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 377 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 377 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 377 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 377 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 377 at risk

Adverse event: Growth of eyelashes
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 377 at risk

Adverse event: Macular oedema
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 377 at risk

Adverse event: Cystoid macular oedema
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 377 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 377 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 377 at risk

Adverse event: Eyelash changes
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 377 at risk

Adverse event: Eyelash hyperpigmentation
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 377 at risk

Adverse event: Eyelash thickening
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 377 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 377 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 377 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 377 at risk

Adverse event: Vital dye staining cornea present
Serious: no
Organ System: Investigations
Frequency: 8 affected / 377 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 377 at risk