Study: NCT03252847

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 11 at risk

Adverse event: Uveitis
Serious: yes
Organ System: Eye disorders
Notes: Assessed by the Investigator as ATIMP-related
Frequency: 1 affected / 11 at risk

Adverse event: Conjunctival abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 11 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 11 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 11 at risk

Adverse event: Intraocular pressure decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 11 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 11 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 11 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 11 at risk

Adverse event: Anterior chamber cell
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 11 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 11 at risk

Adverse event: Eye inflammation
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 11 at risk

Adverse event: Foreign body sensation in eyes
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 11 at risk

Adverse event: Ocular discomfort
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 11 at risk

Adverse event: Cystoid macular oedema
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 11 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 11 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 11 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 11 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 11 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 11 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 11 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 11 at risk

Adverse event: Conjunctival abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 17 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 17 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Intraocular pressure decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 17 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 17 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 17 at risk

Adverse event: Anterior chamber cell
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 17 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 17 at risk

Adverse event: Eye inflammation
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 17 at risk

Adverse event: Foreign body sensation in eyes
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 17 at risk

Adverse event: Ocular discomfort
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 17 at risk

Adverse event: Cystoid macular oedema
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 17 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 17 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 17 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 17 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 17 at risk

Adverse event: Uveitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 17 at risk

Adverse event: Retinal cyst
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 17 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 17 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 17 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 17 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 17 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 4 at risk

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

Adverse event: Anterior chamber cell
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 4 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 4 at risk

Adverse event: Foreign body sensation in eyes
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 4 at risk

Adverse event: Ocular discomfort
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 4 at risk

Adverse event: Cystoid macular oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 4 at risk

Adverse event: Uveitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 4 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 4 at risk

Adverse event: Retinal cyst
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 4 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 4 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 13 at risk

Adverse event: Intraocular pressure increased
Serious: yes
Organ System: Investigations
Notes: Assessed by the Investigator as ATIMP-related
Frequency: 1 affected / 7 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 7 at risk

Adverse event: Intraocular pressure decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 7 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 7 at risk

Adverse event: Anterior chamber cell
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 7 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 7 at risk

Adverse event: Eye inflammation
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 7 at risk

Adverse event: Ocular discomfort
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 7 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 7 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 7 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 7 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 6 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 6 at risk

Adverse event: Anterior chamber cell
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 6 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 6 at risk

Adverse event: Eye inflammation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 6 at risk

Adverse event: Ocular discomfort
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 6 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 6 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk