Study: NCT01140477

Adverse event: Bronchopulmonary aspergillosis allergic
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 153 at risk

Adverse event: High grade B-cell lymphoma, Burkitt-like lymphoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 153 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 153 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 153 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 153 at risk

Adverse event: Cardiac disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 153 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 153 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 153 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 153 at risk

Adverse event: Optic neuropathy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 153 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: Gastrointestinal ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 153 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 153 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 153 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 153 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 153 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 153 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Frequency: 17 affected / 153 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 153 at risk

Adverse event: Corneal oedema
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 153 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 153 at risk

Adverse event: Conjunctivitis allergic
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 153 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 153 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 153 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 76 at risk

Adverse event: Cataract operation complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 76 at risk

Adverse event: Bone sarcoma
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 76 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 76 at risk

Adverse event: Renal artery stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 76 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 76 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 76 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 76 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 76 at risk

Adverse event: Corneal oedema
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 76 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 76 at risk

Adverse event: Conjunctivitis allergic
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 76 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 76 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 76 at risk