Study: NCT01358266

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: 1 subject 44 µg dose group died • a 63-year-old male who suffered a stroke on Day 54 (11 Sep 2012) of study participation.This subject died on Study Day 55 (12 Sep 2012). This SAE was reported as severe, and not related to the study medication.
Frequency: 1 affected / 207 at risk

Adverse event: Uveitis
Serious: yes
Organ System: Eye disorders
Frequency: 6 affected / 207 at risk

Adverse event: Choroiditis
Serious: yes
Organ System: Eye disorders
Frequency: 8 affected / 207 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 4 affected / 207 at risk

Adverse event: Iridocyclitis
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 207 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 207 at risk

Adverse event: Visual acuity reduced
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 207 at risk

Adverse event: Vitritis
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 207 at risk

Adverse event: Cystoid macular oedema
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 207 at risk

Adverse event: Optic neuropathy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 207 at risk

Adverse event: Vitreous haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 207 at risk

Adverse event: Eye haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 207 at risk

Adverse event: Retinal infiltrates
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 207 at risk

Adverse event: Retinal tear
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 207 at risk

Adverse event: Eye infection toxoplasmal
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 207 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 207 at risk

Adverse event: Intraocular pressure increased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 207 at risk

Adverse event: Product residue present
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 207 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 207 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 207 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 207 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 207 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 207 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 207 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 207 at risk

Adverse event: Iridocyclitis
Serious: no
Organ System: Eye disorders
Frequency: 31 affected / 207 at risk

Adverse event: Uveitis
Serious: no
Organ System: Eye disorders
Frequency: 19 affected / 207 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 22 affected / 207 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 18 affected / 207 at risk

Adverse event: Uveitis
Serious: no
Organ System: Eye disorders
Frequency: 16 affected / 207 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 207 at risk

Adverse event: Cystoid macular oedema
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 207 at risk

Adverse event: Choroiditis
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 207 at risk

Adverse event: Cataract subcapsular
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 207 at risk

Adverse event: Macular oedema
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 207 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 34 affected / 207 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 207 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 207 at risk

Adverse event: Vitreous opacities
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 207 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 207 at risk

Adverse event: Uveitis
Serious: yes
Organ System: Eye disorders
Frequency: 10 affected / 205 at risk

Adverse event: Choroiditis
Serious: yes
Organ System: Eye disorders
Frequency: 4 affected / 205 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 205 at risk

Adverse event: Non-infectious endophthalmitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 205 at risk

Adverse event: Iridocyclitis
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 205 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 205 at risk

Adverse event: Visual acuity reduced
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 205 at risk

Adverse event: Vitritis
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 205 at risk

Adverse event: Cystoid macular oedema
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 205 at risk

Adverse event: Eye inflammation
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 205 at risk

Adverse event: Macular oedema
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 205 at risk

Adverse event: Vitreous haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 205 at risk

Adverse event: Anterior chamber inflammation
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 205 at risk

Adverse event: Corneal deposits
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 205 at risk

Adverse event: Corneal epithelium defect
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 205 at risk

Adverse event: Iritis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 205 at risk

Adverse event: Retinal haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 205 at risk

Adverse event: Retinal oedema
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 205 at risk

Adverse event: Endophthalmitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 205 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 205 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 205 at risk

Adverse event: Candida infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 205 at risk

Adverse event: Herpes ophthalmic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 205 at risk

Adverse event: Tooth infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 205 at risk

Adverse event: Intraocular pressure increased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 205 at risk

Adverse event: Fibrin
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 205 at risk

Adverse event: Product residue present
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 205 at risk

Adverse event: Cataract traumatic
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 205 at risk

Adverse event: Corneal abrasion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 205 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 205 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 205 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 205 at risk

Adverse event: Central nervous system lymphoma
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 205 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 205 at risk

Adverse event: Optic neuritis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 205 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 205 at risk

Adverse event: Iridocyclitis
Serious: no
Organ System: Eye disorders
Frequency: 32 affected / 205 at risk

Adverse event: Uveitis
Serious: no
Organ System: Eye disorders
Frequency: 15 affected / 205 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 19 affected / 205 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 22 affected / 205 at risk

Adverse event: Uveitis
Serious: no
Organ System: Eye disorders
Frequency: 15 affected / 205 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 205 at risk

Adverse event: Cystoid macular oedema
Serious: no
Organ System: Eye disorders
Frequency: 15 affected / 205 at risk

Adverse event: Choroiditis
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 205 at risk

Adverse event: Cataract subcapsular
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 205 at risk

Adverse event: Macular oedema
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 205 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 34 affected / 205 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 205 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 205 at risk

Adverse event: Vitreous opacities
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 205 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 205 at risk

Adverse event: Uveitis
Serious: yes
Organ System: Eye disorders
Frequency: 13 affected / 178 at risk

Adverse event: Choroiditis
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 178 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 178 at risk

Adverse event: Non-infectious endophthalmitis
Serious: yes
Organ System: Eye disorders
Frequency: 7 affected / 178 at risk

Adverse event: Iridocyclitis
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 178 at risk

Adverse event: Eye inflammation
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 178 at risk

Adverse event: Uveitis
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 178 at risk

Adverse event: Optic atrophy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 178 at risk

Adverse event: Corneal oedema
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 178 at risk

Adverse event: Ocular hypertension
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 178 at risk

Adverse event: Endophthalmitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 178 at risk

Adverse event: Intraocular pressure increased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 178 at risk

Adverse event: Intraocular pressure decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 178 at risk

Adverse event: Product residue present
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 178 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 178 at risk

Adverse event: Cataract subcapsular
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 178 at risk

Adverse event: Iridocyclitis
Serious: no
Organ System: Eye disorders
Frequency: 30 affected / 178 at risk

Adverse event: Uveitis
Serious: no
Organ System: Eye disorders
Frequency: 29 affected / 178 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 26 affected / 178 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 19 affected / 178 at risk

Adverse event: Uveitis
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 178 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 178 at risk

Adverse event: Cystoid macular oedema
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 178 at risk

Adverse event: Choroiditis
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 178 at risk

Adverse event: Cataract subcapsular
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 178 at risk

Adverse event: Macular oedema
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 178 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 43 affected / 178 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 178 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 178 at risk

Adverse event: Vitreous opacities
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 178 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 178 at risk

Adverse event: Uveitis
Serious: yes
Organ System: Eye disorders
Frequency: 5 affected / 321 at risk

Adverse event: Choroiditis
Serious: yes
Organ System: Eye disorders
Frequency: 6 affected / 321 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 4 affected / 321 at risk

Adverse event: Non-infectious endophthalmitis
Serious: yes
Organ System: Eye disorders
Frequency: 11 affected / 321 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 321 at risk

Adverse event: Vitritis
Serious: yes
Organ System: Eye disorders
Frequency: 4 affected / 321 at risk

Adverse event: Cystoid macular oedema
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 321 at risk

Adverse event: Macular oedema
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 321 at risk

Adverse event: Optic neuropathy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 321 at risk

Adverse event: Choroidal neovascularisation
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 321 at risk

Adverse event: Eye pain
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 321 at risk

Adverse event: Ocular vasculitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 321 at risk

Adverse event: Open angle glaucoma
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 321 at risk

Adverse event: Endophthalmitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 321 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 321 at risk

Adverse event: Intraocular pressure increased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 321 at risk

Adverse event: Product residue present
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 321 at risk

Adverse event: Cataract traumatic
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 321 at risk

Adverse event: Multiple sclerosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 321 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 321 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 321 at risk

Adverse event: Central nervous system lymphoma
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 321 at risk

Adverse event: Breast cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 321 at risk

Adverse event: Intermenstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 321 at risk

Adverse event: Cataract subcapsular
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 321 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 321 at risk

Adverse event: Iridocyclitis
Serious: no
Organ System: Eye disorders
Frequency: 31 affected / 321 at risk

Adverse event: Uveitis
Serious: no
Organ System: Eye disorders
Frequency: 15 affected / 321 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 24 affected / 321 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 321 at risk

Adverse event: Uveitis
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 321 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 32 affected / 321 at risk

Adverse event: Cystoid macular oedema
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 321 at risk

Adverse event: Choroiditis
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 321 at risk

Adverse event: Cataract subcapsular
Serious: no
Organ System: Eye disorders
Frequency: 17 affected / 321 at risk

Adverse event: Macular oedema
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 321 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 44 affected / 321 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 321 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 321 at risk

Adverse event: Vitreous opacities
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 321 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 321 at risk