Study: NCT02299336

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Resulted in death of a subject.
Frequency: 2 affected / 60 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 60 at risk

Adverse event: Worsening congestive heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Acute vision loss secondary to vitreous hemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 60 at risk

Adverse event: Acute vision loss due to worsening cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Worsening staph infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Worsening arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 60 at risk

Adverse event: Worsening coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Led to shortness of breath and altered mental status.
Frequency: 1 affected / 60 at risk

Adverse event: Blocked fistula
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Blocked artery
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Accelerated hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Notes: Caused by a MRSA infection.
Frequency: 1 affected / 60 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 60 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 60 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 60 at risk

Adverse event: Neovascularization elsewhere
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 60 at risk

Adverse event: Neovascularization of the disc
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Worsening cataract
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 60 at risk

Adverse event: Corneal abrasion
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Eye swelling post-cataract extraction
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 60 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Posterior capsule opafication
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Iritis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Optic atrophy
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Decreased vision
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 60 at risk

Adverse event: Ocular sensitivity
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 60 at risk