Study: NCT00412958

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: Anterior chamber inflammation
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 29 at risk

Adverse event: Conjunctival haemorrahge
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 29 at risk

Adverse event: Anterior chamber cell
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 29 at risk

Adverse event: Anterior chamber flare
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 29 at risk

Adverse event: Cataract nuclear
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 29 at risk

Adverse event: Macular oedema
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 29 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 29 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 29 at risk

Adverse event: Eyelid oedema
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 29 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 29 at risk

Adverse event: Retinal tear
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 29 at risk

Adverse event: Retinal depigmentation
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 29 at risk

Adverse event: Ocular discomfort
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 29 at risk

Adverse event: Maculopathy
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 29 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 29 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 29 at risk

Adverse event: Retinal disorder
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 29 at risk

Adverse event: Macular degeneration
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 29 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 29 at risk

Adverse event: Anterior chamber inflammation
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 29 at risk

Adverse event: Conjunctival oedema
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 29 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 29 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 29 at risk

Adverse event: Foreign body sensation in eyes
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 29 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 29 at risk

Adverse event: Corneal disorder
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 29 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 29 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 29 at risk

Adverse event: Corneal bleeding
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 29 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 29 at risk

Adverse event: Photopsia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 29 at risk

Adverse event: Cataract cortical
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 29 at risk

Adverse event: Corneal oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 29 at risk

Adverse event: Macular hole
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 29 at risk

Adverse event: Eye inflammation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 29 at risk

Adverse event: Retinal degeneration
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 29 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 29 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Originally coded to General disorders and administration site conditions
Frequency: 2 affected / 29 at risk

Adverse event: Retinal oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 29 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 33 at risk

Adverse event: Bening pancreatic neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 33 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 33 at risk

Adverse event: Conjunctival haemorrahge
Serious: no
Organ System: Eye disorders
Frequency: 18 affected / 33 at risk

Adverse event: Anterior chamber cell
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 33 at risk

Adverse event: Anterior chamber flare
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 33 at risk

Adverse event: Cataract nuclear
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 33 at risk

Adverse event: Macular oedema
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 33 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 33 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 33 at risk

Adverse event: Eyelid oedema
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 33 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 33 at risk

Adverse event: Retinal tear
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 33 at risk

Adverse event: Retinal depigmentation
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 33 at risk

Adverse event: Ocular discomfort
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 33 at risk

Adverse event: Maculopathy
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 33 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 33 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 33 at risk

Adverse event: Retinal disorder
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 33 at risk

Adverse event: Cataract subcapsular
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 33 at risk

Adverse event: Macular degeneration
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 33 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 33 at risk

Adverse event: Conjunctival oedema
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 33 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 33 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 33 at risk

Adverse event: Foreign body sensation in eyes
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 33 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 33 at risk

Adverse event: Corneal disorder
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 33 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 33 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 33 at risk

Adverse event: Vitreous disorder
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 33 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 33 at risk

Adverse event: Retinal cyst
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 33 at risk

Adverse event: Macular hole
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 33 at risk

Adverse event: Corneal striae
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 33 at risk

Adverse event: Eye inflammation
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 33 at risk

Adverse event: Retinal degeneration
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 33 at risk

Adverse event: Retinal detachment
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 33 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 33 at risk

Adverse event: Intraocular pressure decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 33 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 33 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 33 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 33 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Originally coded to General disorders and administration site conditions
Frequency: 1 affected / 33 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Notes: Originally coded to General disorders and administration site conditions
Frequency: 2 affected / 33 at risk

Adverse event: Retinal oedema
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 33 at risk

Adverse event: Conjunctival haemorrahge
Serious: no
Organ System: Eye disorders
Frequency: 17 affected / 32 at risk

Adverse event: Anterior chamber cell
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 32 at risk

Adverse event: Anterior chamber flare
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 32 at risk

Adverse event: Cataract nuclear
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 32 at risk

Adverse event: Macular oedema
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 32 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 32 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 32 at risk

Adverse event: Eyelid oedema
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 32 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 32 at risk

Adverse event: Retinal tear
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 32 at risk

Adverse event: Retinal depigmentation
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 32 at risk

Adverse event: Ocular discomfort
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 32 at risk

Adverse event: Maculopathy
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 32 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 32 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 32 at risk

Adverse event: Retinal disorder
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 32 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 32 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 32 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 32 at risk

Adverse event: Foreign body sensation in eyes
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 32 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 32 at risk

Adverse event: Corneal disorder
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 32 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 32 at risk

Adverse event: Vitreous disorder
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 32 at risk

Adverse event: Corneal bleeding
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 32 at risk

Adverse event: Photopsia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 32 at risk

Adverse event: Macular hole
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 32 at risk

Adverse event: Corneal striae
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 32 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 32 at risk

Adverse event: Intraocular pressure decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 32 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 32 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Retinal oedema
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 32 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Sinutis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Radius fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Conjunctival haemorrahge
Serious: no
Organ System: Eye disorders
Frequency: 22 affected / 31 at risk

Adverse event: Anterior chamber cell
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 31 at risk

Adverse event: Anterior chamber flare
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 31 at risk

Adverse event: Cataract nuclear
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 31 at risk

Adverse event: Macular oedema
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 31 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 31 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 31 at risk

Adverse event: Eyelid oedema
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 31 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 31 at risk

Adverse event: Retinal tear
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 31 at risk

Adverse event: Retinal depigmentation
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 31 at risk

Adverse event: Ocular discomfort
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 31 at risk

Adverse event: Maculopathy
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 31 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 31 at risk

Adverse event: Retinal disorder
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 31 at risk

Adverse event: Cataract subcapsular
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 31 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 31 at risk

Adverse event: Anterior chamber inflammation
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 31 at risk

Adverse event: Conjunctival oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 31 at risk

Adverse event: Foreign body sensation in eyes
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 31 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 31 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 31 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 31 at risk

Adverse event: Vitreous disorder
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 31 at risk

Adverse event: Photopsia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 31 at risk

Adverse event: Cataract cortical
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 31 at risk

Adverse event: Corneal oedema
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 31 at risk

Adverse event: Retinal cyst
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 31 at risk

Adverse event: Eye inflammation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 31 at risk

Adverse event: Retinal detachment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 31 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 31 at risk

Adverse event: Intraocular pressure decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 31 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 31 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk