Study: NCT00789477

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Colon cancer stage III
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 44 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 44 at risk

Adverse event: Diabetic retinal oedema
Serious: yes
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 44 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Hypertensive emergency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 44 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 44 at risk

Adverse event: Postoperative ileus
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 44 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Squamous cell carcinoma of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 44 at risk

Adverse event: Transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 44 at risk

Adverse event: Visual acuity reduced
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 44 at risk

Adverse event: Visual acuity reduced
Serious: yes
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 44 at risk

Adverse event: Vitreous haemorrhage
Serious: yes
Organ System: Eye disorders
Notes: Study eye
Frequency: 3 affected / 44 at risk

Adverse event: Vitreous haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 44 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 44 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 44 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 2 affected / 44 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 44 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 44 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 2 affected / 44 at risk

Adverse event: Glucose urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Glycosylated haemoglobin increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 44 at risk

Adverse event: Haematocrit decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 44 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 44 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 44 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 44 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Notes: Study eye
Frequency: 1 affected / 44 at risk

Adverse event: Macular oedema
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 44 at risk

Adverse event: Maculopathy
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 2 affected / 44 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 44 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 2 affected / 44 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 3 affected / 44 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 44 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 44 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 2 affected / 44 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 44 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 44 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 2 affected / 44 at risk

Adverse event: Retinal aneurysm
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 44 at risk

Adverse event: Retinal neovascularisation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 44 at risk

Adverse event: Retinal exudates
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 44 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 44 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 44 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 5 affected / 44 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 44 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 2 affected / 44 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 44 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 5 affected / 44 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Blood pressure increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 44 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Device occlusion
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 44 at risk

Adverse event: Lumbar spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 44 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 44 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Parotitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Renal cell carcinoma stage IV
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 44 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Sciatica
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 44 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 44 at risk

Adverse event: Uveitis
Serious: yes
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 44 at risk

Adverse event: Vitreous haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 44 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 44 at risk

Adverse event: Blood potassium increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 44 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 44 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 2 affected / 44 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 44 at risk

Adverse event: Diabetic retinal oedema
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 44 at risk

Adverse event: Diabetic retinal oedema
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 44 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 44 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 6 affected / 44 at risk

Adverse event: Foreign body sensation in eye
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 44 at risk

Adverse event: Glucose urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Glycosylated haemoglobin increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 44 at risk

Adverse event: Haematocrit decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 44 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 44 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 44 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Notes: Study eye
Frequency: 6 affected / 44 at risk

Adverse event: Macular oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 44 at risk

Adverse event: Maculopathy
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 2 affected / 44 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 44 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 44 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 5 affected / 44 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 44 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 44 at risk

Adverse event: Red blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Retinal aneurysm
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 44 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 44 at risk

Adverse event: Retinal aneurysm
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 3 affected / 44 at risk

Adverse event: Retinal exudates
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 4 affected / 44 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 4 affected / 44 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 44 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 3 affected / 44 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 5 affected / 44 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 44 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 44 at risk

Adverse event: Angle closure glaucoma
Serious: yes
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 44 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 44 at risk

Adverse event: Arteriosclerosis coronary artery
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 44 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 44 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 44 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 44 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 44 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 44 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Diverticulum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Endophthalmitis
Serious: yes
Organ System: Infections and infestations
Notes: Study eye
Frequency: 1 affected / 44 at risk

Adverse event: Blood loss anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 44 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 44 at risk

Adverse event: Hypertensive emergency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 44 at risk

Adverse event: Liver function test abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 44 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Non-small cell lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 44 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 44 at risk

Adverse event: Silent myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 44 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 44 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Vitreous haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 44 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 44 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 44 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 4 affected / 44 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 44 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 44 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 44 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 44 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 3 affected / 44 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 44 at risk

Adverse event: Corneal abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Study eye
Frequency: 2 affected / 44 at risk

Adverse event: Diabetic retinal oedema
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 44 at risk

Adverse event: Diabetic retinal oedema
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 3 affected / 44 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 5 affected / 44 at risk

Adverse event: Foreign body sensation in eye
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 44 at risk

Adverse event: Glycosylated haemoglobin increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 44 at risk

Adverse event: Haematocrit decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 44 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 44 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 44 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 44 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 44 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Notes: Study eye
Frequency: 6 affected / 44 at risk

Adverse event: Maculopathy
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 44 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 44 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 44 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 2 affected / 44 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 44 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 44 at risk

Adverse event: Red blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 44 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 44 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 3 affected / 44 at risk

Adverse event: Retinal neovascularisation
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 44 at risk

Adverse event: Retinal exudates
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 44 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 44 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 3 affected / 44 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 44 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 3 affected / 44 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 44 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 2 affected / 44 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 42 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 42 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 42 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 42 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 42 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 42 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 42 at risk

Adverse event: Corneal abrasion
Serious: yes
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 42 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 42 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 42 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 42 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 42 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 42 at risk

Adverse event: Hepatic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 42 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 42 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 42 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 42 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 42 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 42 at risk

Adverse event: Joint capsule rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 42 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 42 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 42 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 42 at risk

Adverse event: Retinal tear
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 42 at risk

Adverse event: Stress urinary incontinence
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 42 at risk

Adverse event: Varices oesophageal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Vitreous haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 42 at risk

Adverse event: Wolff-Parkinson-White syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 42 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 42 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 42 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 42 at risk

Adverse event: Blood potassium increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 42 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 42 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 42 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 2 affected / 42 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 15 affected / 42 at risk

Adverse event: Corneal abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Study eye
Frequency: 2 affected / 42 at risk

Adverse event: Diabetic retinal oedema
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 42 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 42 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 6 affected / 42 at risk

Adverse event: Foreign body sensation in eye
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 42 at risk

Adverse event: Glucose urine present
Serious: no
Organ System: Investigations
Frequency: 3 affected / 42 at risk

Adverse event: Glycosylated haemoglobin increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 42 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 42 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 42 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 42 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Notes: Study eye
Frequency: 5 affected / 42 at risk

Adverse event: Maculopathy
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 4 affected / 42 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 42 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 42 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 3 affected / 42 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 42 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 42 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 4 affected / 42 at risk

Adverse event: Punctate keratitis
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 3 affected / 42 at risk

Adverse event: Retinal aneurysm
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 42 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 42 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 42 at risk

Adverse event: Retinal aneurysm
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 2 affected / 42 at risk

Adverse event: Retinal neovascularisation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 42 at risk

Adverse event: Retinal exudates
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 2 affected / 42 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 42 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 3 affected / 42 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 42 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 2 affected / 42 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 42 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 42 at risk

Adverse event: Blood pressure increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 45 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 45 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 45 at risk

Adverse event: Coagulopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 45 at risk

Adverse event: Cystoid macular oedema
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 45 at risk

Adverse event: Diabetic retinopathy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 45 at risk

Adverse event: Endophthalmitis
Serious: yes
Organ System: Infections and infestations
Notes: Study eye
Frequency: 1 affected / 45 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Maculopathy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 45 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 45 at risk

Adverse event: Vitreous adhesions
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 45 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 45 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 45 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 45 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 45 at risk

Adverse event: Blood potassium increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 45 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 45 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Investigations
Frequency: 3 affected / 45 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 45 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 45 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 5 affected / 45 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 45 at risk

Adverse event: Corneal abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Study eye
Frequency: 3 affected / 45 at risk

Adverse event: Diabetic retinal oedema
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 45 at risk

Adverse event: Diabetic retinal oedema
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 3 affected / 45 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 7 affected / 45 at risk

Adverse event: Foreign body sensation in eye
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 3 affected / 45 at risk

Adverse event: Glucose urine present
Serious: no
Organ System: Investigations
Frequency: 4 affected / 45 at risk

Adverse event: Glycosylated haemoglobin increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 45 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 45 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 45 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 45 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Notes: Study eye
Frequency: 2 affected / 45 at risk

Adverse event: Maculopathy
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 3 affected / 45 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 45 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 45 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 3 affected / 45 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 45 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 3 affected / 45 at risk

Adverse event: Red blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 45 at risk

Adverse event: Retinal aneurysm
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 45 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 45 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 4 affected / 45 at risk

Adverse event: Retinal aneurysm
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 2 affected / 45 at risk

Adverse event: Retinal neovascularisation
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 45 at risk

Adverse event: Retinal exudates
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 3 affected / 45 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 2 affected / 45 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 2 affected / 45 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 45 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 45 at risk