Study: NCT01613716

Adverse event: Persistent corneal epithelial defect
Serious: yes
Organ System: Eye disorders
Notes: Patient had a persistent corneal defect after vitrectomy surgery and implantation of Ozurdex. Subsequently healed.
Frequency: 1 affected / 30 at risk

Adverse event: Area of tractional retinal detachment versus retinoschisis surgery eye
Serious: yes
Organ System: Eye disorders
Notes: Patient had an are of possible tractional retinal detachment versus retinoschisis noted throughout the surgery after vitrectomy surgery.
Frequency: 1 affected / 30 at risk

Adverse event: Peptic ulcers-hospitalized for stomach pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Patient had a bout of stomach and was hospitalized and diagnosed with peptic ulcers.
Frequency: 1 affected / 30 at risk

Adverse event: Root canal infection
Serious: yes
Organ System: Infections and infestations
Notes: Patient had a root canal and developed an infection afterwards
Frequency: 1 affected / 30 at risk

Adverse event: Removal of basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Patient had a biopsy of the nose that was subsequently diagnosed as a basal cell carcinoma
Frequency: 1 affected / 30 at risk

Adverse event: Ozurdex placment on fovea
Serious: yes
Organ System: Eye disorders
Notes: After placement of Ozurdex it adhered to the fovea, requiring a second surgery where it went back into the normal position.
Frequency: 1 affected / 30 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Patient subsequently underwent a CABG procedure, had a previous history of cardiac issues.
Frequency: 1 affected / 30 at risk

Adverse event: Increase in cataract surgical eye
Serious: no
Organ System: Eye disorders
Notes: Increase in cataract in the surgical eye
Frequency: 2 affected / 30 at risk

Adverse event: Increase in cataract fellow eye
Serious: no
Organ System: Eye disorders
Notes: Increase in cataract surgery fellow eye
Frequency: 6 affected / 30 at risk

Adverse event: Increase in intraocular pressure
Serious: no
Organ System: Eye disorders
Notes: Increase in intraocular pressure
Frequency: 7 affected / 30 at risk

Adverse event: Worsening of diabetic disease fellow eye
Serious: no
Organ System: Eye disorders
Notes: Worsening of diabetic eye disease or cystoid macular edema
Frequency: 8 affected / 30 at risk

Adverse event: Road traffic accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Patient was involved motor vehicle collusion no hospitalizations
Frequency: 2 affected / 30 at risk

Adverse event: worsening of posterior capsular opacity
Serious: no
Organ System: Eye disorders
Notes: Worsening of posterior capsular opacity study eye
Frequency: 3 affected / 30 at risk

Adverse event: worsening of posterior capsular opacity fellow eye
Serious: no
Organ System: Eye disorders
Notes: As described above
Frequency: 1 affected / 30 at risk

Adverse event: respiratory flu
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory flu
Frequency: 1 affected / 30 at risk

Adverse event: Dental infection
Serious: no
Organ System: Infections and infestations
Notes: Infection after dental procedure
Frequency: 1 affected / 30 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Was treated in the emergency room for poison ivy.
Frequency: 1 affected / 30 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: found during a sleep study during a cardiology visit.
Frequency: 1 affected / 30 at risk

Adverse event: broken patella
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 30 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 30 at risk

Adverse event: increased cystoid macular edema study eye
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 30 at risk

Adverse event: Transient Ischemic Avent
Serious: no
Organ System: Nervous system disorders
Notes: Patient had history of previous TIAs
Frequency: 1 affected / 30 at risk

Adverse event: Epithelial defect study eye
Serious: no
Organ System: Eye disorders
Notes: Patient had reported epithelial defect after vitrectomy surgery.
Frequency: 4 affected / 30 at risk

Adverse event: Increased itching both eyes
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 30 at risk

Adverse event: Increase in pain study eye
Serious: no
Organ System: Eye disorders
Notes: Patient noted increased pain in surgical eye
Frequency: 2 affected / 30 at risk

Adverse event: Increased diabetic retinopathy study eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Increase of dryness of the eyes
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 30 at risk

Adverse event: Trouble breathing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: patient was diagnosed with pneumonia
Frequency: 1 affected / 30 at risk

Adverse event: Cartoid blockage
Serious: no
Organ System: Cardiac disorders
Notes: Patient had previous history of blockage was scheduled for outpatient stent
Frequency: 1 affected / 30 at risk

Adverse event: loss of vision fellow eye
Serious: no
Organ System: Eye disorders
Notes: Patient reported decrease vision fellow eye
Frequency: 1 affected / 30 at risk

Adverse event: small choroidal study eye
Serious: no
Organ System: Eye disorders
Notes: Choroidal was found postoperatively from vitrectomy surgery.
Frequency: 1 affected / 30 at risk

Adverse event: Vitreous hemorrhage study eye
Serious: no
Organ System: Eye disorders
Notes: Patient had a vitreous hemorrhage of study eye
Frequency: 2 affected / 30 at risk

Adverse event: Syncope after injection
Serious: no
Organ System: General disorders
Notes: patient had syncope episode after protocol injection of ozurdex
Frequency: 1 affected / 30 at risk

Adverse event: Trouble reading
Serious: no
Organ System: Eye disorders
Notes: Patient reported difficulty with reading both eyes
Frequency: 1 affected / 30 at risk

Adverse event: Nausea, vomiting diarrhea,dehydration
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Went to the emergency room the night of surgery with complications of anesthesia from vitrectomy surgery- was not admitted
Frequency: 1 affected / 30 at risk

Adverse event: Worsening of Parkinson's tremors
Serious: no
Organ System: Nervous system disorders
Notes: Patient had past medical history of Parkinson's
Frequency: 1 affected / 30 at risk

Adverse event: Sarcoidosis Flare
Serious: no
Organ System: Immune system disorders
Notes: Patient had a flare of previously diagnosed sarcoidosis
Frequency: 1 affected / 30 at risk

Adverse event: Foreign body sensation of eyes
Serious: no
Organ System: Eye disorders
Notes: Patient reported feeling like something was in their eyes and irritating it- nothing was found in their eyes.
Frequency: 1 affected / 30 at risk

Adverse event: Injury to hip an back
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Patient had a work related injury requiring physical therapy
Frequency: 1 affected / 30 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Patient reported diarrhea, did not seek medical attention
Frequency: 1 affected / 30 at risk

Adverse event: Subconjunctival hemorrhage fellow eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Digestion issues
Serious: no
Organ System: Gastrointestinal disorders
Notes: Patient had reported digestion issue later diagnosed with GERD
Frequency: 1 affected / 30 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Reported sinus infections
Frequency: 2 affected / 30 at risk

Adverse event: Increased floaters fellow eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 30 at risk

Adverse event: Decreased television vision fellow eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Glare with vision at night
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Tearing in both eyes
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk