Study: NCT00284050

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 51 at risk

Adverse event: Endophthalmitis (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Vitreous haemorrhage (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Allergic transfusion reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 51 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 51 at risk

Adverse event: Radius fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 51 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 51 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 51 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 51 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 51 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 51 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 51 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 51 at risk

Adverse event: Conjunctival haemorrhage (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 51 at risk

Adverse event: Conjunctival hyperaemia (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 51 at risk

Adverse event: Conjunctivitis (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Conjunctivitis (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Corneal disorder (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 51 at risk

Adverse event: Eye irritation (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 51 at risk

Adverse event: Eye pain (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 51 at risk

Adverse event: Eye pruritus (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 51 at risk

Adverse event: Eyelid oedema (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Foreign body sensation in eyes (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 51 at risk

Adverse event: Lacrimation increased (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 51 at risk

Adverse event: Macular oedema (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 51 at risk

Adverse event: Ocular hyperaemia (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 51 at risk

Adverse event: Retinal disorder (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 51 at risk

Adverse event: Retinal exudates (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 51 at risk

Adverse event: Retinal haemorrhage (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Visual acuity reduced (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Visual disturbance (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 51 at risk

Adverse event: Vitreous floaters (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Vitreous haemorrhage (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 51 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 51 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 51 at risk

Adverse event: Intraocular pressure increased (Fellow eye)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 51 at risk

Adverse event: Intraocular pressure increased (Study eye)
Serious: no
Organ System: Investigations
Frequency: 6 affected / 51 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 51 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Endophthalmitis (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Retinal artery occlusion (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Retinal ischaemia (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Infected dermal cyst
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 51 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 51 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 51 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 51 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 51 at risk

Adverse event: Cataract (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 51 at risk

Adverse event: Conjunctival haemorrhage (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 51 at risk

Adverse event: Conjunctival hyperaemia (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Conjunctivitis (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Corneal disorder (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 51 at risk

Adverse event: Eye irritation (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Eye pain (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 51 at risk

Adverse event: Eye pruritus (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 51 at risk

Adverse event: Foreign body sensation in eyes (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 51 at risk

Adverse event: Lacrimation increased (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 51 at risk

Adverse event: Macular oedema (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 51 at risk

Adverse event: Ocular hyperaemia (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 51 at risk

Adverse event: Retinal disorder (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Retinal exudates (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Retinal haemorrhage (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 51 at risk

Adverse event: Visual acuity reduced (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 51 at risk

Adverse event: Visual disturbance (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 51 at risk

Adverse event: Vitreous floaters (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 51 at risk

Adverse event: Vitreous haemorrhage (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 51 at risk

Adverse event: Vitreous haemorrhage (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 51 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 51 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 51 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 51 at risk

Adverse event: Intraocular pressure increased (Fellow eye)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 51 at risk

Adverse event: Intraocular pressure increased (Study eye)
Serious: no
Organ System: Investigations
Frequency: 15 affected / 51 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 51 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 51 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 49 at risk

Adverse event: Retinal detachment (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 49 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Diabetic gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 49 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 49 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 49 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 49 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 49 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 49 at risk

Adverse event: Cataract (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 49 at risk

Adverse event: Conjunctival haemorrhage (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 49 at risk

Adverse event: Conjunctival hyperaemia (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 49 at risk

Adverse event: Conjunctivitis (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 49 at risk

Adverse event: Conjunctivitis (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 49 at risk

Adverse event: Eye irritation (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 49 at risk

Adverse event: Eye pain (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 49 at risk

Adverse event: Eye pruritus (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 49 at risk

Adverse event: Eyelid oedema (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 49 at risk

Adverse event: Foreign body sensation in eyes (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 49 at risk

Adverse event: Ocular hyperaemia (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 49 at risk

Adverse event: Retinal exudates (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 49 at risk

Adverse event: Retinal haemorrhage (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 49 at risk

Adverse event: Visual acuity reduced (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 49 at risk

Adverse event: Visual disturbance (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 49 at risk

Adverse event: Vitreous haemorrhage (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 49 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 49 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 49 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 49 at risk

Adverse event: Intraocular pressure increased (Study eye)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 49 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 49 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 49 at risk