Study: NCT01223378

Adverse event: Gastrointestinal Hemorrage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal bleed
Frequency: 1 affected / 82 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Gastric Ulcer
Frequency: 1 affected / 82 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 82 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 82 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 82 at risk

Adverse event: Instillation site pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 82 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 82 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 82 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 82 at risk

Adverse event: Abnormal Sensation in the Eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 82 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 82 at risk

Adverse event: Maculopathy
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 82 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 82 at risk

Adverse event: Instillation site reaction
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 82 at risk

Adverse event: Migraine with aura
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 82 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 84 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 84 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 84 at risk

Adverse event: Instillation site pain
Serious: no
Organ System: General disorders
Frequency: 14 affected / 84 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Keratopathy
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Keratitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Photopsia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 83 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 83 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 83 at risk

Adverse event: Instillation site pain
Serious: no
Organ System: General disorders
Frequency: 10 affected / 83 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 83 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 83 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 83 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 83 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 83 at risk

Adverse event: Instillation site erythema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 83 at risk

Adverse event: Instillation site lacrimation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 83 at risk

Adverse event: Instillation site reaction
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 83 at risk

Adverse event: Instillation site discomfort
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 83 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 81 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 81 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 81 at risk

Adverse event: Instillation site pain
Serious: no
Organ System: General disorders
Frequency: 14 affected / 81 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 81 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 81 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 81 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 81 at risk

Adverse event: Growth of eyelashes
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 81 at risk

Adverse event: Instillation site erythema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 81 at risk

Adverse event: Instillation site pruritus
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 81 at risk

Adverse event: Instillation site irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 81 at risk

Adverse event: Gastric ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Bleeding gastric ulcer
Frequency: 1 affected / 82 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Acute myocardial infarction
Frequency: 1 affected / 82 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 82 at risk

Adverse event: Instillation site pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 82 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 82 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 82 at risk

Adverse event: Keratopathy
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 82 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 82 at risk

Adverse event: Conjunctival follicles
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 82 at risk

Adverse event: Eye Lid Edema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 82 at risk

Adverse event: Instillation site lacrimation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 82 at risk