Study: NCT03066258

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 6 at risk

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

Adverse event: Visual Acuity Reduced/Impairment
Serious: no
Organ System: Eye disorders
Notes: Visual Acuity Reduced \& Impairment will be presented as a group term including the AE preferred terms (PTs) of "Visual Acuity Reduced" and "Visual Impairment"
Frequency: 3 affected / 6 at risk

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

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

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

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 6 at risk

Adverse event: Eye inflammation
Serious: no
Organ System: Eye disorders
Notes: Intraocular Inflammation is a group term including AE preferred terms of 'Anterior Chamber Cell', 'Anterior Chamber Flare', and 'Anterior Chamber Inflammation'.
Frequency: 4 affected / 6 at risk

Adverse event: Dry age-related macular degeneration
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 6 at risk

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

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Deep vein thrombosis postoperative
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue 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: Intraocular pressure increased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 6 at risk

Adverse event: Visual Acuity Reduced/Impairment
Serious: no
Organ System: Eye disorders
Notes: Visual Acuity Reduced \& Impairment will be presented as a group term including the AE preferred terms (PTs) of "Visual Acuity Reduced" and "Visual Impairment"
Frequency: 3 affected / 6 at risk

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

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

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

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

Adverse event: Retinal pigmentary changes (depigmentation, pigment epitheliopathy & pigmentation)
Serious: no
Organ System: Eye disorders
Notes: Retinal pigmentary changes is a group term including AE preferred terms of 'Retinal Depigmentation', 'Retinal Pigment Epitheliopathy', and 'Retinal Pigmentation'.
Frequency: 3 affected / 6 at risk

Adverse event: Eye inflammation
Serious: no
Organ System: Eye disorders
Notes: Intraocular Inflammation is a group term including AE preferred terms of 'Anterior Chamber Cell', 'Anterior Chamber Flare', and 'Anterior Chamber Inflammation'.
Frequency: 3 affected / 6 at risk

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

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 6 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 6 at risk

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

Adverse event: Visual Acuity Reduced/Impairment
Serious: no
Organ System: Eye disorders
Notes: Visual Acuity Reduced \& Impairment will be presented as a group term including the AE preferred terms (PTs) of "Visual Acuity Reduced" and "Visual Impairment"
Frequency: 1 affected / 6 at risk

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

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 6 at risk

Adverse event: Retinal pigmentary changes (depigmentation, pigment epitheliopathy & pigmentation)
Serious: no
Organ System: Eye disorders
Notes: Retinal pigmentary changes is a group term including AE preferred terms of 'Retinal Depigmentation', 'Retinal Pigment Epitheliopathy', and 'Retinal Pigmentation'.
Frequency: 3 affected / 6 at risk

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

Adverse event: Eye inflammation
Serious: no
Organ System: Eye disorders
Notes: Intraocular Inflammation is a group term including AE preferred terms of 'Anterior Chamber Cell', 'Anterior Chamber Flare', and 'Anterior Chamber Inflammation'.
Frequency: 3 affected / 6 at risk

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

Adverse event: Endophthalmitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 12 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 12 at risk

Adverse event: Visual Acuity Reduced/Impairment
Serious: no
Organ System: Eye disorders
Notes: Visual Acuity Reduced \& Impairment will be presented as a group term including the AE preferred terms (PTs) of "Visual Acuity Reduced" and "Visual Impairment"
Frequency: 1 affected / 12 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 12 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 12 at risk

Adverse event: Retinal degeneration
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 12 at risk

Adverse event: Photopsia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 12 at risk

Adverse event: Retinal pigmentary changes (depigmentation, pigment epitheliopathy & pigmentation)
Serious: no
Organ System: Eye disorders
Notes: Retinal pigmentary changes is a group term including AE preferred terms of 'Retinal Depigmentation', 'Retinal Pigment Epitheliopathy', and 'Retinal Pigmentation'.
Frequency: 12 affected / 12 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 12 at risk

Adverse event: Eye inflammation
Serious: no
Organ System: Eye disorders
Notes: Intraocular Inflammation is a group term including AE preferred terms of 'Anterior Chamber Cell', 'Anterior Chamber Flare', and 'Anterior Chamber Inflammation'.
Frequency: 3 affected / 12 at risk

Adverse event: Metamorphopsia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 12 at risk

Adverse event: Retinal thickening
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 12 at risk

Adverse event: Erythema of eyelid
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 12 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 12 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 12 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 12 at risk

Adverse event: Visual impairment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 12 at risk

Adverse event: Colitis ischaemic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 12 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 12 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 12 at risk

Adverse event: Visual Acuity Reduced/Impairment
Serious: no
Organ System: Eye disorders
Notes: Visual Acuity Reduced \& Impairment will be presented as a group term including the AE preferred terms (PTs) of "Visual Acuity Reduced" and "Visual Impairment"
Frequency: 1 affected / 12 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 12 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 12 at risk

Adverse event: Retinal degeneration
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 12 at risk

Adverse event: Photopsia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 12 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 12 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 12 at risk

Adverse event: Retinal pigmentary changes (depigmentation, pigment epitheliopathy & pigmentation)
Serious: no
Organ System: Eye disorders
Notes: Retinal pigmentary changes is a group term including AE preferred terms of 'Retinal Depigmentation', 'Retinal Pigment Epitheliopathy', and 'Retinal Pigmentation'.
Frequency: 11 affected / 12 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 12 at risk

Adverse event: Eye inflammation
Serious: no
Organ System: Eye disorders
Notes: Intraocular Inflammation is a group term including AE preferred terms of 'Anterior Chamber Cell', 'Anterior Chamber Flare', and 'Anterior Chamber Inflammation'.
Frequency: 2 affected / 12 at risk

Adverse event: Metamorphopsia
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 12 at risk

Adverse event: Dry age-related macular degeneration
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 12 at risk

Adverse event: Erythema of eyelid
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 12 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 12 at risk