Study: NCT02688556

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 372 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 372 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 372 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 372 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 372 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 372 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 30 affected / 372 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 372 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 372 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 372 at risk

Adverse event: Instillation site pain
Serious: no
Organ System: General disorders
Frequency: 90 affected / 372 at risk

Adverse event: Instillation site lacrimation
Serious: no
Organ System: General disorders
Frequency: 4 affected / 372 at risk

Adverse event: Instillation site reaction
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 372 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 372 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 372 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 372 at risk

Adverse event: Foreign body sensation in eyes
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 372 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 372 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 372 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 372 at risk

Adverse event: Perforated ulcer
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 372 at risk

Adverse event: Spinal osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 372 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 18 affected / 372 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 372 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 372 at risk

Adverse event: Instillation site pain
Serious: no
Organ System: General disorders
Frequency: 16 affected / 372 at risk

Adverse event: Instillation site reaction
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 372 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 372 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 372 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 372 at risk

Adverse event: Foreign body sensation in eyes
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 372 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 372 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 372 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 372 at risk