Study: NCT00344968

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 185 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 185 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 185 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 185 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 185 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 185 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 185 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 185 at risk

Adverse event: Cardiac valve disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 185 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 185 at risk

Adverse event: Cardiovascular insufficiency
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 185 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 185 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 185 at risk

Adverse event: Left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 185 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 185 at risk

Adverse event: Nodal arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 185 at risk

Adverse event: Blindness
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 185 at risk

Adverse event: Blindness
Serious: yes
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 185 at risk

Adverse event: Diabetic retinal oedema
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 185 at risk

Adverse event: Eye haemorrhage
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 185 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 2 affected / 185 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 185 at risk

Adverse event: Macular oedema
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 185 at risk

Adverse event: Macular oedema
Serious: yes
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 185 at risk

Adverse event: Maculopathy
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 2 affected / 185 at risk

Adverse event: Maculopathy
Serious: yes
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 185 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 3 affected / 185 at risk

Adverse event: Vitreous haemorrhage
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 6 affected / 185 at risk

Adverse event: Vitreous haemorrhage
Serious: yes
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 8 affected / 185 at risk

Adverse event: Vitritis
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 185 at risk

Adverse event: Vitritis
Serious: yes
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 185 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 185 at risk

Adverse event: Impaired gastric emptying
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 185 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 185 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 185 at risk

Adverse event: Adverse drug reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 185 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 185 at risk

Adverse event: Cyst
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 185 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 185 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 185 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 185 at risk

Adverse event: Polyp
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 185 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 185 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 185 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 185 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Arteriovenous graft site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Blister infected
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 185 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 185 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 185 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Staphylococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 185 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 185 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 185 at risk

Adverse event: Forearm fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 185 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 185 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 185 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 185 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 185 at risk

Adverse event: Tendon rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 185 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 185 at risk

Adverse event: Traumatic shock
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 185 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 185 at risk

Adverse event: Wound haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 185 at risk

Adverse event: Catheterisation cardiac
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 185 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 185 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 185 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 185 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 185 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 185 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 185 at risk

Adverse event: Rheumatoid nodule
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 185 at risk

Adverse event: Adenoma benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 185 at risk

Adverse event: Metastatic carcinoma of the bladder
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 185 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 185 at risk

Adverse event: Salivary gland neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 185 at risk

Adverse event: Brain stem infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 185 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 185 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 185 at risk

Adverse event: Diabetic coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 185 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 185 at risk

Adverse event: Thalamic infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 185 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 185 at risk

Adverse event: Renal disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 185 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 185 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 185 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 185 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 185 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 185 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 185 at risk

Adverse event: Cataract operation
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Study eye
Frequency: 33 affected / 185 at risk

Adverse event: Cataract operation
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Fellow eye
Frequency: 32 affected / 185 at risk

Adverse event: Coronary artery bypass
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 185 at risk

Adverse event: Cryotherapy
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Fellow eye
Frequency: 1 affected / 185 at risk

Adverse event: Eye operation
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Study eye
Frequency: 1 affected / 185 at risk

Adverse event: Gallbladder operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 185 at risk

Adverse event: Glaucoma surgery
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Study eye
Frequency: 1 affected / 185 at risk

Adverse event: Glaucoma surgery
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Fellow eye
Frequency: 1 affected / 185 at risk

Adverse event: Hernia repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 185 at risk

Adverse event: Leg amputation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 185 at risk

Adverse event: Renal transplant
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 185 at risk

Adverse event: Retinal operation
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Study eye
Frequency: 1 affected / 185 at risk

Adverse event: Stent placement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 185 at risk

Adverse event: Thyroidectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 185 at risk

Adverse event: Tumour excision
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 185 at risk

Adverse event: Uterine polypectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 185 at risk

Adverse event: Vitrectomy
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Study eye
Frequency: 16 affected / 185 at risk

Adverse event: Vitrectomy
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Fellow eye
Frequency: 13 affected / 185 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 185 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 185 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 185 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 185 at risk

Adverse event: Malignant hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 185 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 185 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 53 affected / 185 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 46 affected / 185 at risk

Adverse event: Cataract subcapsular
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 8 affected / 185 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 20 affected / 185 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 11 affected / 185 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 9 affected / 185 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 9 affected / 185 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 22 affected / 185 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 11 affected / 185 at risk

Adverse event: Maculopathy
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 16 affected / 185 at risk

Adverse event: Maculopathy
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 9 affected / 185 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 13 affected / 185 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 11 affected / 185 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 6 affected / 185 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 4 affected / 185 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 11 affected / 185 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 13 affected / 185 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 4 affected / 185 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 17 affected / 185 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 14 affected / 185 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 7 affected / 185 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 12 affected / 185 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 25 affected / 185 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 22 affected / 185 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 185 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 185 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 185 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 185 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 185 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 185 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 185 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 185 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Notes: #Study eye
Frequency: 21 affected / 185 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Notes: #Fellow eye
Frequency: 22 affected / 185 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 185 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 185 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 185 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 185 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 185 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 29 affected / 185 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 375 at risk

Adverse event: Coagulopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 375 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 375 at risk

Adverse event: Acute left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 375 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 375 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 375 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 375 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 375 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 375 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 375 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 375 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 375 at risk

Adverse event: Cardiopulmonary failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 375 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 375 at risk

Adverse event: Ischaemic cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 375 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 14 affected / 375 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 375 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 375 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 375 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 375 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 375 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 375 at risk

Adverse event: Anterior capsule contraction
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 375 at risk

Adverse event: Conjunctival ulcer
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 375 at risk

Adverse event: Corneal thinning
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 375 at risk

Adverse event: Diabetic retinal oedema
Serious: yes
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 375 at risk

Adverse event: Diabetic retinopathy
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 375 at risk

Adverse event: Eye pain
Serious: yes
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 375 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 12 affected / 375 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 375 at risk

Adverse event: Macular hole
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 2 affected / 375 at risk

Adverse event: Maculopathy
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 2 affected / 375 at risk

Adverse event: Maculopathy
Serious: yes
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 375 at risk

Adverse event: Optic ischaemic neuropathy
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 375 at risk

Adverse event: Posterior capsule rupture
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 375 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 2 affected / 375 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 375 at risk

Adverse event: Retinal vein occlusion
Serious: yes
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 375 at risk

Adverse event: Scleral thinning
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 375 at risk

Adverse event: Vitreous haemorrhage
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 10 affected / 375 at risk

Adverse event: Vitreous haemorrhage
Serious: yes
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 5 affected / 375 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 375 at risk

Adverse event: Abdominal pain lower
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 375 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 375 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 375 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 375 at risk

Adverse event: Faecaloma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 375 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 375 at risk

Adverse event: Hiatus hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 375 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 375 at risk

Adverse event: Intra-abdominal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 375 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 375 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 375 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 375 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 375 at risk

Adverse event: Hernia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 375 at risk

Adverse event: Hernia obstructive
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 375 at risk

Adverse event: Impaired healing
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 375 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 375 at risk

Adverse event: Sudden cardiac death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 375 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 375 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 375 at risk

Adverse event: Hepatic steatosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 375 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 375 at risk

Adverse event: Appendicitis perforated
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 375 at risk

Adverse event: Arthritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 375 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 375 at risk

Adverse event: Catheter site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 375 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 375 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 375 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 375 at risk

Adverse event: Encephalitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 375 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 375 at risk

Adverse event: Endophthalmitis
Serious: yes
Organ System: Infections and infestations
Notes: #Study eye
Frequency: 2 affected / 375 at risk

Adverse event: Eye infection fungal
Serious: yes
Organ System: Infections and infestations
Notes: #Study eye
Frequency: 1 affected / 375 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 375 at risk

Adverse event: Hepatitis C
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 375 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 375 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 375 at risk

Adverse event: Kidney infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 375 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 375 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 375 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 375 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 375 at risk

Adverse event: Pneumonia klebsiella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 375 at risk

Adverse event: Pneumonia legionella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 375 at risk

Adverse event: Pneumonia staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 375 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 375 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 375 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 375 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 375 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 375 at risk

Adverse event: Cataract operation complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: #Fellow eye
Frequency: 1 affected / 375 at risk

Adverse event: Chemical burns of eye
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: #Study eye
Frequency: 1 affected / 375 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 375 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 375 at risk

Adverse event: Foreign body
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: #Study eye
Frequency: 1 affected / 375 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 375 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 375 at risk

Adverse event: Limb injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 375 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 375 at risk

Adverse event: Pelvic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 375 at risk

Adverse event: Respiratory fume inhalation disorder
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 375 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 375 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 375 at risk

Adverse event: Splenic injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 375 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 375 at risk

Adverse event: Diagnostic procedure
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 375 at risk

Adverse event: Intraocular pressure increased
Serious: yes
Organ System: Investigations
Notes: #Study eye
Frequency: 12 affected / 375 at risk

Adverse event: Intraocular pressure increased
Serious: yes
Organ System: Investigations
Notes: #Fellow eye
Frequency: 1 affected / 375 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 375 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 375 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 375 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 375 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 375 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 375 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 375 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 375 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 375 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 375 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 375 at risk

Adverse event: Neuropathic arthropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 375 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 375 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 375 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 375 at risk

Adverse event: Spinal osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 375 at risk

Adverse event: Spondylolisthesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 375 at risk

Adverse event: Adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 375 at risk

Adverse event: Brain neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 375 at risk

Adverse event: Breast cancer female
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 375 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 375 at risk

Adverse event: Hepatic cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 375 at risk

Adverse event: Plasma cell myeloma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 375 at risk

Adverse event: Oesophageal neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 375 at risk

Adverse event: Ovarian cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 375 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 375 at risk

Adverse event: Small cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 375 at risk

Adverse event: Brain stem infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 375 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 375 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 375 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 375 at risk

Adverse event: Dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 375 at risk

Adverse event: Diabetic autonomic neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 375 at risk

Adverse event: Embolic cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 375 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 375 at risk

Adverse event: Hypertensive encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 375 at risk

Adverse event: Lacunar infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 375 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 375 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 375 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 375 at risk

Adverse event: Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 375 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 11 affected / 375 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 375 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 375 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 375 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 375 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 375 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 375 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 375 at risk

Adverse event: Pleurisy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 375 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 375 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 375 at risk

Adverse event: Amputation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 375 at risk

Adverse event: Arterial stent insertion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 375 at risk

Adverse event: Arteriovenous graft
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 375 at risk

Adverse event: Bladder operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 375 at risk

Adverse event: Blepharoplasty
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Study eye
Frequency: 1 affected / 375 at risk

Adverse event: Blepharoplasty
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Fellow eye
Frequency: 1 affected / 375 at risk

Adverse event: Cardiac pacemaker insertion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 375 at risk

Adverse event: Cataract operation
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Study eye
Frequency: 188 affected / 375 at risk

Adverse event: Cataract operation
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Fellow eye
Frequency: 85 affected / 375 at risk

Adverse event: Cholecystectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 375 at risk

Adverse event: Colon operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 375 at risk

Adverse event: Coronary artery bypass
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 375 at risk

Adverse event: Eye excision
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Fellow eye
Frequency: 1 affected / 375 at risk

Adverse event: Glaucoma surgery
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Study eye
Frequency: 7 affected / 375 at risk

Adverse event: Hip arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 375 at risk

Adverse event: Intraocular lens implant
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Study eye
Frequency: 1 affected / 375 at risk

Adverse event: Knee arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 375 at risk

Adverse event: Leg amputation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 375 at risk

Adverse event: Pancreas transplant
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 375 at risk

Adverse event: Removal of foreign body
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 375 at risk

Adverse event: Removal of foreign body from eye
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Study eye
Frequency: 1 affected / 375 at risk

Adverse event: Retinal operation
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Study eye
Frequency: 1 affected / 375 at risk

Adverse event: Retinal operation
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Fellow eye
Frequency: 1 affected / 375 at risk

Adverse event: Sinus operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 375 at risk

Adverse event: Toe amputation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 375 at risk

Adverse event: Trabeculectomy
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Study eye
Frequency: 10 affected / 375 at risk

Adverse event: Trabeculoplasty
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Study eye
Frequency: 3 affected / 375 at risk

Adverse event: Vascular cauterisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 375 at risk

Adverse event: Vitrectomy
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Study eye
Frequency: 19 affected / 375 at risk

Adverse event: Vitrectomy
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Fellow eye
Frequency: 25 affected / 375 at risk

Adverse event: Arteritis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 375 at risk

Adverse event: Blood pressure fluctuation
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 375 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 375 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 375 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 375 at risk

Adverse event: Ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 375 at risk

Adverse event: Lymphoedema
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 375 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 375 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 375 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 33 affected / 375 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 171 affected / 375 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 109 affected / 375 at risk

Adverse event: Cataract subcapsular
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 28 affected / 375 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 43 affected / 375 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 23 affected / 375 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 23 affected / 375 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 27 affected / 375 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 51 affected / 375 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 17 affected / 375 at risk

Adverse event: Maculopathy
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 22 affected / 375 at risk

Adverse event: Maculopathy
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 16 affected / 375 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 67 affected / 375 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 17 affected / 375 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 32 affected / 375 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 19 affected / 375 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 9 affected / 375 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 28 affected / 375 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 21 affected / 375 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 39 affected / 375 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 25 affected / 375 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 13 affected / 375 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 26 affected / 375 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 38 affected / 375 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 36 affected / 375 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 375 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 375 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 375 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 375 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 375 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 375 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 375 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 375 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Notes: #Study eye
Frequency: 129 affected / 375 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Notes: #Fellow eye
Frequency: 40 affected / 375 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 375 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 31 affected / 375 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 375 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 19 affected / 375 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 375 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 43 affected / 375 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 393 at risk

Adverse event: Blood loss anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 393 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 393 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 393 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 393 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 393 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 393 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 393 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 393 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 393 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 393 at risk

Adverse event: Bundle branch block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 393 at risk

Adverse event: Bundle branch block left
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 393 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 393 at risk

Adverse event: Cardiac disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 393 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 393 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 393 at risk

Adverse event: Cardiac fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 393 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 393 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 393 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 393 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 393 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 393 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 393 at risk

Adverse event: Sinus arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 393 at risk

Adverse event: Tracheo-oesophageal fistula
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 393 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 393 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 393 at risk

Adverse event: Amaurosis fugax
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 393 at risk

Adverse event: Angle closure glaucoma
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 2 affected / 393 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 393 at risk

Adverse event: Cataract subcapsular
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 393 at risk

Adverse event: Diabetic retinopathy
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 393 at risk

Adverse event: Diabetic retinopathy
Serious: yes
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 393 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 12 affected / 393 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 3 affected / 393 at risk

Adverse event: Hyphaema
Serious: yes
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 393 at risk

Adverse event: Hypotony of eye
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 393 at risk

Adverse event: Iris adhesions
Serious: yes
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 393 at risk

Adverse event: Iris bombe
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 393 at risk

Adverse event: Iris incarceration
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 393 at risk

Adverse event: Keratitis
Serious: yes
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 393 at risk

Adverse event: Lens dislocation
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 393 at risk

Adverse event: Lens dislocation
Serious: yes
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 393 at risk

Adverse event: Maculopathy
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 2 affected / 393 at risk

Adverse event: Maculopathy
Serious: yes
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 2 affected / 393 at risk

Adverse event: Ocular hypertension
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 2 affected / 393 at risk

Adverse event: Open angle glaucoma
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 2 affected / 393 at risk

Adverse event: Retinal artery embolism
Serious: yes
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 393 at risk

Adverse event: Retinal artery occlusion
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 393 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 4 affected / 393 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 393 at risk

Adverse event: Retinal tear
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 393 at risk

Adverse event: Retinal tear
Serious: yes
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 393 at risk

Adverse event: Uveitis
Serious: yes
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 393 at risk

Adverse event: Visual acuity reduced
Serious: yes
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 2 affected / 393 at risk

Adverse event: Visual impairment
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 393 at risk

Adverse event: Vitreous haemorrhage
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 8 affected / 393 at risk

Adverse event: Vitreous haemorrhage
Serious: yes
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 9 affected / 393 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Diabetic gastroparesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 393 at risk

Adverse event: Enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Gastrointestinal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Mesenteric artery embolism
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 393 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Retroperitoneum cyst
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 393 at risk

Adverse event: Impaired healing
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 393 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 393 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 393 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 393 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 393 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 393 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Arthritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 393 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 393 at risk

Adverse event: Cellulitis staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Diabetic foot infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Endophthalmitis
Serious: yes
Organ System: Infections and infestations
Notes: #Fellow eye
Frequency: 1 affected / 393 at risk

Adverse event: Enterocolitis infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 393 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 393 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 393 at risk

Adverse event: Kidney infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Liver abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 393 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Lyme disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Necrotising fasciitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 393 at risk

Adverse event: Post procedural infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Prostate infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 393 at risk

Adverse event: Sepsis syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Tracheostomy infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 393 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 393 at risk

Adverse event: Wound infection staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 393 at risk

Adverse event: Cataract operation complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: #Study eye
Frequency: 1 affected / 393 at risk

Adverse event: Ocular procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: #Study eye
Frequency: 1 affected / 393 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 393 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 393 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 393 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 393 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 393 at risk

Adverse event: Lumbar vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 393 at risk

Adverse event: Pelvic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 393 at risk

Adverse event: Post concussion syndrome
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 393 at risk

Adverse event: Ulna fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 393 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: #Study eye
Frequency: 1 affected / 393 at risk

Adverse event: Blood glucose decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 393 at risk

Adverse event: Blood glucose increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 393 at risk

Adverse event: Catheterisation cardiac
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 393 at risk

Adverse event: Full blood count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 393 at risk

Adverse event: Heart rate decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 393 at risk

Adverse event: Hysteroscopy
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 393 at risk

Adverse event: International normalised ratio increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 393 at risk

Adverse event: Intraocular pressure increased
Serious: yes
Organ System: Investigations
Notes: #Study eye
Frequency: 20 affected / 393 at risk

Adverse event: Intraocular pressure increased
Serious: yes
Organ System: Investigations
Notes: #Fellow eye
Frequency: 2 affected / 393 at risk

Adverse event: Oxygen saturation decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 393 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 393 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 393 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 393 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 393 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 393 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 393 at risk

Adverse event: Fluid retention
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 393 at risk

Adverse event: Gout
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 393 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 393 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 393 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 393 at risk

Adverse event: Shock hypoglycaemic
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 393 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 393 at risk

Adverse event: Arthropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 393 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 393 at risk

Adverse event: Flank pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 393 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 393 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 393 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 393 at risk

Adverse event: Polymyalgia rheumatica
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 393 at risk

Adverse event: Spondylitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 393 at risk

Adverse event: Synovitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 393 at risk

Adverse event: Bone cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 393 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 393 at risk

Adverse event: Colon cancer stage II
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 393 at risk

Adverse event: Colorectal cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 393 at risk

Adverse event: Endometrial cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 393 at risk

Adverse event: Gastric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 393 at risk

Adverse event: Gastrooesophageal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 393 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 393 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 393 at risk

Adverse event: Thyroid neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 393 at risk

Adverse event: Uterine cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 393 at risk

Adverse event: Carotid artery disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 393 at risk

Adverse event: Carotid artery occlusion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 393 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 393 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 393 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 393 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 393 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 393 at risk

Adverse event: Lacunar infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 393 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 393 at risk

Adverse event: Myelopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 393 at risk

Adverse event: Neurological symptom
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 393 at risk

Adverse event: Spinal cord disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 393 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 393 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 393 at risk

Adverse event: Vascular dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 393 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 393 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 393 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 393 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 10 affected / 393 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 393 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 393 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 393 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 393 at risk

Adverse event: Vocal cord thickening
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 393 at risk

Adverse event: Decubitus ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 393 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 393 at risk

Adverse event: Neuropathic ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 393 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 393 at risk

Adverse event: Angioplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 393 at risk

Adverse event: Ankle operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 393 at risk

Adverse event: Cardiac pacemaker insertion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 393 at risk

Adverse event: Carotid artery stent insertion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 393 at risk

Adverse event: Cataract operation
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Study eye
Frequency: 231 affected / 393 at risk

Adverse event: Cataract operation
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Fellow eye
Frequency: 87 affected / 393 at risk

Adverse event: Coronary arterial stent insertion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 393 at risk

Adverse event: Coronary artery bypass
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 393 at risk

Adverse event: Dialysis device insertion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 393 at risk

Adverse event: Dupuytren's contracture operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 393 at risk

Adverse event: Foot operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 393 at risk

Adverse event: Glaucoma surgery
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Study eye
Frequency: 8 affected / 393 at risk

Adverse event: Glaucoma surgery
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Fellow eye
Frequency: 5 affected / 393 at risk

Adverse event: Haemorrhoid operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 393 at risk

Adverse event: Hip arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 393 at risk

Adverse event: Hysterectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 393 at risk

Adverse event: Inguinal hernia repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 393 at risk

Adverse event: Lens extraction
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Study eye
Frequency: 1 affected / 393 at risk

Adverse event: Intraocular lens implant
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Study eye
Frequency: 2 affected / 393 at risk

Adverse event: Iridotomy
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Study eye
Frequency: 1 affected / 393 at risk

Adverse event: Knee arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 393 at risk

Adverse event: Leg amputation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 393 at risk

Adverse event: Penile prosthesis insertion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 393 at risk

Adverse event: Percutaneous coronary intervention
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 393 at risk

Adverse event: Ptosis repair
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Study eye
Frequency: 1 affected / 393 at risk

Adverse event: Retinal operation
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Study eye
Frequency: 2 affected / 393 at risk

Adverse event: Retinal operation
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Fellow eye
Frequency: 1 affected / 393 at risk

Adverse event: Rotator cuff repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 393 at risk

Adverse event: Shoulder arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 393 at risk

Adverse event: Toe amputation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 393 at risk

Adverse event: Trabeculectomy
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Study eye
Frequency: 22 affected / 393 at risk

Adverse event: Trabeculoplasty
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Study eye
Frequency: 10 affected / 393 at risk

Adverse event: Transurethral prostatectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 393 at risk

Adverse event: Umbilical hernia repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 393 at risk

Adverse event: Vitrectomy
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Study eye
Frequency: 23 affected / 393 at risk

Adverse event: Vitrectomy
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Fellow eye
Frequency: 27 affected / 393 at risk

Adverse event: Wound closure
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Study eye
Frequency: 1 affected / 393 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 393 at risk

Adverse event: Arteriosclerosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 393 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 393 at risk

Adverse event: Peripheral artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 393 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 393 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 393 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 393 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 42 affected / 393 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 213 affected / 393 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 121 affected / 393 at risk

Adverse event: Cataract subcapsular
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 24 affected / 393 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 50 affected / 393 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 22 affected / 393 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 17 affected / 393 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 22 affected / 393 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 65 affected / 393 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 11 affected / 393 at risk

Adverse event: Maculopathy
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 33 affected / 393 at risk

Adverse event: Maculopathy
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 22 affected / 393 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 68 affected / 393 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 18 affected / 393 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 25 affected / 393 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 20 affected / 393 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 17 affected / 393 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 20 affected / 393 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 14 affected / 393 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 35 affected / 393 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 23 affected / 393 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 31 affected / 393 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 20 affected / 393 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 46 affected / 393 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 49 affected / 393 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 393 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 393 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 393 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 393 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 393 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 393 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 393 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 393 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Notes: #Study eye
Frequency: 169 affected / 393 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Notes: #Fellow eye
Frequency: 50 affected / 393 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 24 affected / 393 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 393 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 22 affected / 393 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 25 affected / 393 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 393 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 57 affected / 393 at risk