Study: NCT00306852

Adverse event: Neoplasm malignant
Serious: yes
Organ System: General disorders
Notes: Specific Cancer type or cause - unknown.
Frequency: 2 affected / 105 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 105 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Study Team/Coordinating Center was unable to obtain the specific cause of death for 12 Subjects.
Frequency: 7 affected / 105 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: SQUAMOUS CELL CARCINOMA OF THE TRACHEA
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 105 at risk

Adverse event: Choroidal effusion
Serious: no
Organ System: Eye disorders
Frequency: 18 affected / 105 at risk

Adverse event: SHALLOW OR FLAT ANTERIOR CHAMBER
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 105 at risk

Adverse event: WOUND LEAK
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 105 at risk

Adverse event: Hyphaema
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 105 at risk

Adverse event: Aqueous misdirection
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 105 at risk

Adverse event: SUPRACHOROIDAL HEMORRHAGE
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 105 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 105 at risk

Adverse event: DECOMPRESSION RETINOPATHY
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 105 at risk

Adverse event: Cystoid macular oedema
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 105 at risk

Adverse event: PERSISTENT CORNEAL EDEMA
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 105 at risk

Adverse event: Dysaesthesia
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 105 at risk

Adverse event: PERSISTENT DIPLOPIA
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 105 at risk

Adverse event: Tenon's cyst
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 105 at risk

Adverse event: BLEB LEAK
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 105 at risk

Adverse event: Hypotony maculopathy
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 105 at risk

Adverse event: ENDOPHTHALMITIS/BLEBITIS
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 105 at risk

Adverse event: CHRONIC OR RECURRENT IRITIS
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 105 at risk

Adverse event: Retinal detachment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 105 at risk

Adverse event: Ulcerative keratitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 105 at risk

Adverse event: SERIOUS COMPLICATIONS
Serious: no
Organ System: Eye disorders
Notes: Serious complications were defined as postoperative complications requiring a re-operation to manage the complication and/or resulting in loss of 2 or more lines of Snellen VA.
Frequency: 21 affected / 105 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 107 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 107 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Study Team/Coordinating Center was unable to obtain the specific cause of death for 12 Subjects.
Frequency: 6 affected / 107 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 107 at risk

Adverse event: Bone cancer
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: CLASSIFICATION UNKNOWN
Frequency: 1 affected / 107 at risk

Adverse event: MYCARDIAL INFRACTION
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 107 at risk

Adverse event: CORONARY ARTERY BYPASS SURGERY
Serious: yes
Organ System: Surgical and medical procedures
Notes: MORE SPECIFIC CAUSE OF DEATH UNAVAILABLE.
Frequency: 1 affected / 107 at risk

Adverse event: Choroidal effusion
Serious: no
Organ System: Eye disorders
Frequency: 17 affected / 107 at risk

Adverse event: SHALLOW OR FLAT ANTERIOR CHAMBER
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 107 at risk

Adverse event: WOUND LEAK
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 107 at risk

Adverse event: Hyphaema
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 107 at risk

Adverse event: Aqueous misdirection
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 107 at risk

Adverse event: SUPRACHOROIDAL HEMORRHAGE
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 107 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 107 at risk

Adverse event: Cystoid macular oedema
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 107 at risk

Adverse event: PERSISTENT CORNEAL EDEMA
Serious: no
Organ System: Eye disorders
Frequency: 17 affected / 107 at risk

Adverse event: Dysaesthesia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 107 at risk

Adverse event: PERSISTENT DIPLOPIA
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 107 at risk

Adverse event: Tenon's cyst
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 107 at risk

Adverse event: Hypotony maculopathy
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 107 at risk

Adverse event: TUBE EROSION
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 107 at risk

Adverse event: ENDOPHTHALMITIS/BLEBITIS
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 107 at risk

Adverse event: CHRONIC OR RECURRENT IRITIS
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 107 at risk

Adverse event: TUBE OBSTRUCTION
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 107 at risk

Adverse event: Retinal detachment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 107 at risk

Adverse event: SERIOUS COMPLICATIONS
Serious: no
Organ System: Eye disorders
Notes: Serious complications were defined as postoperative complications requiring a re-operation to manage the complication and/or resulting in loss of 2 or more lines of Snellen VA.
Frequency: 24 affected / 107 at risk