Study: NCT00473330

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 124 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 124 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 124 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 124 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 124 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 124 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 124 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 124 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 124 at risk

Adverse event: Cataract (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 124 at risk

Adverse event: Choroidal neovascularisation (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 124 at risk

Adverse event: Cystoid macular oedema (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 124 at risk

Adverse event: Macular oedema (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 124 at risk

Adverse event: Macular oedema (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 124 at risk

Adverse event: Posterior capsule opacification (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 124 at risk

Adverse event: Retinal detachment (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)-study eye
Frequency: 1 affected / 124 at risk

Adverse event: Retinal haemorrhage (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 124 at risk

Adverse event: Retinal neovascularisation (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 124 at risk

Adverse event: Visual acuity reduced (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 124 at risk

Adverse event: Visual acuity reduced (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 124 at risk

Adverse event: Vitreous haemorrhage (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 2 affected / 124 at risk

Adverse event: Vitreous haemorrhage (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 5 affected / 124 at risk

Adverse event: Large intestine polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Duodenal ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Impaired gastric emptying
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Retroperitoneal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 124 at risk

Adverse event: Hepatic cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 124 at risk

Adverse event: Abscess oral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Cholecystitis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 124 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 124 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 124 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 124 at risk

Adverse event: Blood glucose increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 124 at risk

Adverse event: Blood potassium increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 124 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 124 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 124 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 124 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 124 at risk

Adverse event: Costochondritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Gastrointestinal neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 124 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 124 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 124 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 124 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 124 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 124 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 124 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 124 at risk

Adverse event: Diabetic nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 124 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 124 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 124 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 124 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 124 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Accelerated hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 124 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 124 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 124 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 124 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 124 at risk

Adverse event: Blepharitis (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 124 at risk

Adverse event: Blepharitis (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 124 at risk

Adverse event: Cataract (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 25 affected / 124 at risk

Adverse event: Cataract (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 20 affected / 124 at risk

Adverse event: Cataract cortical (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 8 affected / 124 at risk

Adverse event: Cataract cortical (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 9 affected / 124 at risk

Adverse event: Cataract nuclear (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 6 affected / 124 at risk

Adverse event: Cataract nuclear (S)
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 7 affected / 124 at risk

Adverse event: Cataract subcapsular (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 7 affected / 124 at risk

Adverse event: Cataract subcapsular (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 4 affected / 124 at risk

Adverse event: Conjunctival haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 2 affected / 124 at risk

Adverse event: Conjunctival haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 40 affected / 124 at risk

Adverse event: Cystoid macular oedema (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 8 affected / 124 at risk

Adverse event: Cystoid macular oedema (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 5 affected / 124 at risk

Adverse event: Diabetic retinal oedema (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 19 affected / 124 at risk

Adverse event: Diabetic retinal oedema (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 7 affected / 124 at risk

Adverse event: Diabetic retinopathy (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 15 affected / 124 at risk

Adverse event: Diabetic retinopathy (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 8 affected / 124 at risk

Adverse event: Dry eye (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 6 affected / 124 at risk

Adverse event: Dry eye (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 7 affected / 124 at risk

Adverse event: Eye irritation (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 9 affected / 124 at risk

Adverse event: Eye pain (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 4 affected / 124 at risk

Adverse event: Eye pain (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 24 affected / 124 at risk

Adverse event: Eye pruritus (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 8 affected / 124 at risk

Adverse event: Foreign body sensation in eyes (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 6 affected / 124 at risk

Adverse event: Lacrimation increased (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 8 affected / 124 at risk

Adverse event: Macular fibrosis (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 13 affected / 124 at risk

Adverse event: Macular fibrosis (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 7 affected / 124 at risk

Adverse event: Macular oedema (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 40 affected / 124 at risk

Adverse event: Macular oedema (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 24 affected / 124 at risk

Adverse event: Ocular hyperaemia (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 14 affected / 124 at risk

Adverse event: Photophobia (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 124 at risk

Adverse event: Posterior capsule opacification (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 3 affected / 124 at risk

Adverse event: Retinal aneurysm (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 5 affected / 124 at risk

Adverse event: Retinal aneurysm (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 3 affected / 124 at risk

Adverse event: Retinal exudates (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=study eye
Frequency: 24 affected / 124 at risk

Adverse event: Retinal exudates (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 25 affected / 124 at risk

Adverse event: Retinal haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 24 affected / 124 at risk

Adverse event: Retinal haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 24 affected / 124 at risk

Adverse event: Retinal neovascularisation (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 15 affected / 124 at risk

Adverse event: Retinal neovascularisation (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 16 affected / 124 at risk

Adverse event: Vision blurred (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 5 affected / 124 at risk

Adverse event: Vision blurred (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 7 affected / 124 at risk

Adverse event: Visual acuity reduced (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 8 affected / 124 at risk

Adverse event: Vitreous detachment (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 16 affected / 124 at risk

Adverse event: Vitreous detachment (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 18 affected / 124 at risk

Adverse event: Vitreous floaters (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 5 affected / 124 at risk

Adverse event: Vitreous floaters (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 7 affected / 124 at risk

Adverse event: Vitreous haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 8 affected / 124 at risk

Adverse event: Vitreous haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 16 affected / 124 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 124 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 124 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 124 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 124 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 124 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 124 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 6 affected / 124 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 124 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 124 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 124 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 124 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 124 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 124 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 124 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 124 at risk

Adverse event: Corneal abrasion (S)
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: (S)=study eye
Frequency: 7 affected / 124 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 124 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 124 at risk

Adverse event: Intraocular pressure increased (F)
Serious: no
Organ System: Investigations
Notes: (F)=fellow eye
Frequency: 4 affected / 124 at risk

Adverse event: Intraocular pressure increased (S)
Serious: no
Organ System: Investigations
Notes: (S)=study eye
Frequency: 3 affected / 124 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 124 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 124 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 124 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 124 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 124 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 124 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 124 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 124 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 124 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 124 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 124 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 124 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 124 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 124 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 124 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 124 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 124 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 124 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 23 affected / 124 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 124 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 124 at risk

Adverse event: Blood loss anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 124 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 124 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 124 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 124 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 124 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 124 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 124 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 124 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 124 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 124 at risk

Adverse event: Heart valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 124 at risk

Adverse event: Ischaemic cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 124 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 124 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 124 at risk

Adverse event: Cataract (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 3 affected / 124 at risk

Adverse event: Cataract (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 124 at risk

Adverse event: Choroidal neovascularisation (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 124 at risk

Adverse event: Cystoid macular oedema (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 124 at risk

Adverse event: Macular oedema (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 124 at risk

Adverse event: Macular oedema (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 124 at risk

Adverse event: Posterior capsule opacification (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 124 at risk

Adverse event: Retinal detachment (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)-study eye
Frequency: 2 affected / 124 at risk

Adverse event: Retinal haemorrhage (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 124 at risk

Adverse event: Retinal neovascularisation (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 124 at risk

Adverse event: Visual acuity reduced (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 3 affected / 124 at risk

Adverse event: Visual acuity reduced (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 124 at risk

Adverse event: Vitreous detachment (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 124 at risk

Adverse event: Vitreous haemorrhage (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 3 affected / 124 at risk

Adverse event: Vitreous haemorrhage (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 5 affected / 124 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Large intestine polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Duodenal ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Impaired gastric emptying
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Retroperitoneal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 124 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 124 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 124 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 124 at risk

Adverse event: Hepatic cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 124 at risk

Adverse event: Abscess oral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Cholecystitis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Endophthalmitis (F)
Serious: yes
Organ System: Infections and infestations
Notes: (F)=fellow eye
Frequency: 1 affected / 124 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Gas gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 124 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 124 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 124 at risk

Adverse event: Limb crushing injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 124 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 124 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 124 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 124 at risk

Adverse event: Blood glucose increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 124 at risk

Adverse event: Blood potassium increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 124 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 124 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 124 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 124 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 124 at risk

Adverse event: Costochondritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Rheumatoid arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 124 at risk

Adverse event: Gastrointestinal neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 124 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 124 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 124 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 124 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 124 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 124 at risk

Adverse event: Metabolic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 124 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 124 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 124 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 124 at risk

Adverse event: Diabetic nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 124 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 124 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 124 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 124 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 124 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 124 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 124 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 124 at risk

Adverse event: Accelerated hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 124 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 124 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 124 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 124 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 124 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 124 at risk

Adverse event: Blepharitis (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 2 affected / 124 at risk

Adverse event: Blepharitis (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 2 affected / 124 at risk

Adverse event: Cataract (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 28 affected / 124 at risk

Adverse event: Cataract (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 21 affected / 124 at risk

Adverse event: Cataract cortical (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 9 affected / 124 at risk

Adverse event: Cataract cortical (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 10 affected / 124 at risk

Adverse event: Cataract nuclear (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 8 affected / 124 at risk

Adverse event: Cataract nuclear (S)
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 8 affected / 124 at risk

Adverse event: Cataract subcapsular (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 5 affected / 124 at risk

Adverse event: Cataract subcapsular (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 4 affected / 124 at risk

Adverse event: Conjunctival haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 12 affected / 124 at risk

Adverse event: Conjunctival haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 45 affected / 124 at risk

Adverse event: Cystoid macular oedema (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 10 affected / 124 at risk

Adverse event: Cystoid macular oedema (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 6 affected / 124 at risk

Adverse event: Diabetic retinal oedema (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 22 affected / 124 at risk

Adverse event: Diabetic retinal oedema (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 7 affected / 124 at risk

Adverse event: Diabetic retinopathy (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 16 affected / 124 at risk

Adverse event: Diabetic retinopathy (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 8 affected / 124 at risk

Adverse event: Dry eye (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 7 affected / 124 at risk

Adverse event: Dry eye (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 8 affected / 124 at risk

Adverse event: Eye irritation (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 9 affected / 124 at risk

Adverse event: Eye pain (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 7 affected / 124 at risk

Adverse event: Eye pain (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 28 affected / 124 at risk

Adverse event: Eye pruritus (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 8 affected / 124 at risk

Adverse event: Foreign body sensation in eyes (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 6 affected / 124 at risk

Adverse event: Lacrimation increased (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 8 affected / 124 at risk

Adverse event: Macular fibrosis (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 14 affected / 124 at risk

Adverse event: Macular fibrosis (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 10 affected / 124 at risk

Adverse event: Macular oedema (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 47 affected / 124 at risk

Adverse event: Macular oedema (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 26 affected / 124 at risk

Adverse event: Ocular hyperaemia (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 14 affected / 124 at risk

Adverse event: Photophobia (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 124 at risk

Adverse event: Posterior capsule opacification (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 4 affected / 124 at risk

Adverse event: Retinal aneurysm (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 6 affected / 124 at risk

Adverse event: Retinal aneurysm (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 4 affected / 124 at risk

Adverse event: Retinal exudates (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=study eye
Frequency: 27 affected / 124 at risk

Adverse event: Retinal exudates (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 28 affected / 124 at risk

Adverse event: Retinal haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 25 affected / 124 at risk

Adverse event: Retinal haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 26 affected / 124 at risk

Adverse event: Retinal neovascularisation (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 19 affected / 124 at risk

Adverse event: Retinal neovascularisation (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 18 affected / 124 at risk

Adverse event: Vision blurred (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 6 affected / 124 at risk

Adverse event: Vision blurred (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 7 affected / 124 at risk

Adverse event: Visual acuity reduced (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 10 affected / 124 at risk

Adverse event: Vitreous detachment (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 18 affected / 124 at risk

Adverse event: Vitreous detachment (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 19 affected / 124 at risk

Adverse event: Vitreous floaters (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 8 affected / 124 at risk

Adverse event: Vitreous floaters (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 10 affected / 124 at risk

Adverse event: Vitreous haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 11 affected / 124 at risk

Adverse event: Vitreous haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 18 affected / 124 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 124 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 124 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 124 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 124 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 124 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 124 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 8 affected / 124 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 124 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 124 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 124 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 124 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 124 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 124 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 124 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 124 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 124 at risk

Adverse event: Corneal abrasion (S)
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: (S)=study eye
Frequency: 7 affected / 124 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 124 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 124 at risk

Adverse event: Intraocular pressure increased (F)
Serious: no
Organ System: Investigations
Notes: (F)=fellow eye
Frequency: 6 affected / 124 at risk

Adverse event: Intraocular pressure increased (S)
Serious: no
Organ System: Investigations
Notes: (S)=study eye
Frequency: 9 affected / 124 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 124 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 124 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 124 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 124 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 124 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 124 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 124 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 124 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 124 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 124 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 124 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 124 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 124 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 124 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 124 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 124 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 124 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 124 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 28 affected / 124 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 124 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 125 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 125 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 125 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 125 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 125 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 125 at risk

Adverse event: Dilated cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 125 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 125 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 125 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 125 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 125 at risk

Adverse event: Cataract (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 3 affected / 125 at risk

Adverse event: Diabetic retinal oedema (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 125 at risk

Adverse event: Diabetic retinal oedema (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 125 at risk

Adverse event: Glaucoma (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 125 at risk

Adverse event: Retinal detachment (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 2 affected / 125 at risk

Adverse event: Visual acuity reduced (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 125 at risk

Adverse event: Vitreous haemorrhage (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 4 affected / 125 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Colitis ischaemic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 125 at risk

Adverse event: Colitis ulcerative
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 125 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 125 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 125 at risk

Adverse event: Cholecystitis chronic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 125 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 125 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 125 at risk

Adverse event: Cardiac infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 125 at risk

Adverse event: Cholecystitis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Clostridial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Device related sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Empyema
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Endophthalmitis (S)
Serious: yes
Organ System: Infections and infestations
Notes: (S)=study eye
Frequency: 1 affected / 125 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 125 at risk

Adverse event: Pelvic abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 125 at risk

Adverse event: Pneumonia staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Arteriovenous fistula site haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 125 at risk

Adverse event: Cataract traumatic (S)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: (S)=study eye
Frequency: 1 affected / 125 at risk

Adverse event: Comminuted fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 125 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 125 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 125 at risk

Adverse event: Medication error (S)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: (S)=study eye
Frequency: 1 affected / 125 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 125 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 125 at risk

Adverse event: Troponin I increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 125 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 125 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 125 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 125 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 125 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 125 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 125 at risk

Adverse event: Muscle spasms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 125 at risk

Adverse event: Hepatic cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 125 at risk

Adverse event: Melanoma recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 125 at risk

Adverse event: Rectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 125 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 125 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 125 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 125 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 125 at risk

Adverse event: Delusion
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 125 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 125 at risk

Adverse event: Renal artery arteriosclerosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 125 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 125 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 125 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 125 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 125 at risk

Adverse event: Endometrial hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 125 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Pulmonary thrombosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 125 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 125 at risk

Adverse event: Arteriosclerosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 125 at risk

Adverse event: Peripheral artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 125 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 125 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 125 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 125 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 125 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 125 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 125 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 9 affected / 125 at risk

Adverse event: Blepharitis (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 7 affected / 125 at risk

Adverse event: Blepharitis (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 8 affected / 125 at risk

Adverse event: Cataract (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 30 affected / 125 at risk

Adverse event: Cataract (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 28 affected / 125 at risk

Adverse event: Cataract cortical (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 7 affected / 125 at risk

Adverse event: Cataract cortical (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 9 affected / 125 at risk

Adverse event: Cataract nuclear (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 6 affected / 125 at risk

Adverse event: Cataract nuclear (S)
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 6 affected / 125 at risk

Adverse event: Cataract subcapsular (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 5 affected / 125 at risk

Adverse event: Cataract subcapsular (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 9 affected / 125 at risk

Adverse event: Conjunctival haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 19 affected / 125 at risk

Adverse event: Conjunctival haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 70 affected / 125 at risk

Adverse event: Cystoid macular oedema (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 12 affected / 125 at risk

Adverse event: Cystoid macular oedema (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 8 affected / 125 at risk

Adverse event: Diabetic retinal oedema (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 23 affected / 125 at risk

Adverse event: Diabetic retinal oedema (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 7 affected / 125 at risk

Adverse event: Diabetic retinopathy (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 12 affected / 125 at risk

Adverse event: Diabetic retinopathy (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 2 affected / 125 at risk

Adverse event: Dry eye (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 12 affected / 125 at risk

Adverse event: Dry eye (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 13 affected / 125 at risk

Adverse event: Eye irritation (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 13 affected / 125 at risk

Adverse event: Eye pain (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 10 affected / 125 at risk

Adverse event: Eye pain (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 35 affected / 125 at risk

Adverse event: Eye pruritus (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 7 affected / 125 at risk

Adverse event: Foreign body sensation in eyes (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 17 affected / 125 at risk

Adverse event: Lacrimation increased (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 8 affected / 125 at risk

Adverse event: Macular fibrosis (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 15 affected / 125 at risk

Adverse event: Macular fibrosis (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 8 affected / 125 at risk

Adverse event: Macular oedema (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 45 affected / 125 at risk

Adverse event: Macular oedema (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 25 affected / 125 at risk

Adverse event: Ocular hyperaemia (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 20 affected / 125 at risk

Adverse event: Photophobia (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 7 affected / 125 at risk

Adverse event: Posterior capsule opacification (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 10 affected / 125 at risk

Adverse event: Retinal aneurysm (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 10 affected / 125 at risk

Adverse event: Retinal aneurysm (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 10 affected / 125 at risk

Adverse event: Retinal exudates (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=study eye
Frequency: 22 affected / 125 at risk

Adverse event: Retinal exudates (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 28 affected / 125 at risk

Adverse event: Retinal haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 24 affected / 125 at risk

Adverse event: Retinal haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 19 affected / 125 at risk

Adverse event: Retinal neovascularisation (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 12 affected / 125 at risk

Adverse event: Vision blurred (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 7 affected / 125 at risk

Adverse event: Vision blurred (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 15 affected / 125 at risk

Adverse event: Visual acuity reduced (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 8 affected / 125 at risk

Adverse event: Vitreous detachment (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 20 affected / 125 at risk

Adverse event: Vitreous detachment (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 21 affected / 125 at risk

Adverse event: Vitreous floaters (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 15 affected / 125 at risk

Adverse event: Vitreous floaters (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 22 affected / 125 at risk

Adverse event: Vitreous haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 10 affected / 125 at risk

Adverse event: Vitreous haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 4 affected / 125 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 125 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 125 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 125 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 125 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 125 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 125 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 8 affected / 125 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 125 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 11 affected / 125 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 125 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 125 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 125 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 125 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 125 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 125 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 125 at risk

Adverse event: Corneal abrasion (S)
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: (S)=study eye
Frequency: 4 affected / 125 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 125 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 125 at risk

Adverse event: Intraocular pressure increased (F)
Serious: no
Organ System: Investigations
Notes: (F)=fellow eye
Frequency: 13 affected / 125 at risk

Adverse event: Intraocular pressure increased (S)
Serious: no
Organ System: Investigations
Notes: (S)=study eye
Frequency: 26 affected / 125 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 17 affected / 125 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 125 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 125 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 125 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 125 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 125 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 125 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 125 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 125 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 125 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 125 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 125 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 125 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 125 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 125 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 125 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 125 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 125 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 27 affected / 125 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 125 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 125 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 125 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 125 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 125 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 125 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 125 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 125 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 125 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 125 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 125 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 125 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 125 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 125 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 125 at risk

Adverse event: Cataract (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 125 at risk

Adverse event: Corneal degeneration (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 125 at risk

Adverse event: Diabetic retinal oedema (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 125 at risk

Adverse event: Iritis (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 125 at risk

Adverse event: Optic ischaemic neuropathy (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 125 at risk

Adverse event: Retinal detachment (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 2 affected / 125 at risk

Adverse event: Retinal haemorrhage (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 125 at risk

Adverse event: Retinal tear (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 125 at risk

Adverse event: Visual acuity reduced (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 125 at risk

Adverse event: Vitreous haemorrhage (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 3 affected / 125 at risk

Adverse event: Vitreous haemorrhage (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 3 affected / 125 at risk

Adverse event: Colitis ischaemic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Erosive oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 125 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 125 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 125 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 125 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 125 at risk

Adverse event: Acute sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 125 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Diabetic foot infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 125 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 125 at risk

Adverse event: Gastrointestinal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Helicobacter gastritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Keratitis bacterial (S)
Serious: yes
Organ System: Infections and infestations
Notes: (S)=study eye
Frequency: 1 affected / 125 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 125 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Urinary tract infection bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Cataract traumatic (S)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: (S)=study eye
Frequency: 1 affected / 125 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 125 at risk

Adverse event: Foreign body
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 125 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 125 at risk

Adverse event: Limb injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 125 at risk

Adverse event: Medication error (S)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: (S)=study eye
Frequency: 2 affected / 125 at risk

Adverse event: Postoperative ileus
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 125 at risk

Adverse event: Full blood count decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 125 at risk

Adverse event: Intraocular pressure increased (S)
Serious: yes
Organ System: Investigations
Notes: (S)=study eye
Frequency: 1 affected / 125 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 125 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 125 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 125 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 125 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 125 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 125 at risk

Adverse event: Cervical spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 125 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 125 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 125 at risk

Adverse event: Adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 125 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 125 at risk

Adverse event: Breast cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 125 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 125 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 125 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 125 at risk

Adverse event: Thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 125 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 125 at risk

Adverse event: Diabetic hyperosmolar coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 125 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 125 at risk

Adverse event: Lacunar infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 125 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 125 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 125 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 125 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 125 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 125 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 125 at risk

Adverse event: Nephrotic syndrome
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 125 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 125 at risk

Adverse event: Stress urinary incontinence
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 125 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Toe amputation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 125 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 125 at risk

Adverse event: Arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 125 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 125 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 125 at risk

Adverse event: Hypertensive emergency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 125 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 125 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 125 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 125 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 6 affected / 125 at risk

Adverse event: Blepharitis (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 9 affected / 125 at risk

Adverse event: Blepharitis (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 7 affected / 125 at risk

Adverse event: Cataract (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 23 affected / 125 at risk

Adverse event: Cataract (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 21 affected / 125 at risk

Adverse event: Cataract cortical (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 7 affected / 125 at risk

Adverse event: Cataract cortical (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 8 affected / 125 at risk

Adverse event: Cataract nuclear (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 4 affected / 125 at risk

Adverse event: Cataract nuclear (S)
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 6 affected / 125 at risk

Adverse event: Cataract subcapsular (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 5 affected / 125 at risk

Adverse event: Cataract subcapsular (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 9 affected / 125 at risk

Adverse event: Conjunctival haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 19 affected / 125 at risk

Adverse event: Conjunctival haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 66 affected / 125 at risk

Adverse event: Cystoid macular oedema (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 12 affected / 125 at risk

Adverse event: Cystoid macular oedema (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 4 affected / 125 at risk

Adverse event: Diabetic retinal oedema (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 23 affected / 125 at risk

Adverse event: Diabetic retinal oedema (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 10 affected / 125 at risk

Adverse event: Diabetic retinopathy (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 9 affected / 125 at risk

Adverse event: Diabetic retinopathy (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 4 affected / 125 at risk

Adverse event: Dry eye (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 10 affected / 125 at risk

Adverse event: Dry eye (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 11 affected / 125 at risk

Adverse event: Eye irritation (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 12 affected / 125 at risk

Adverse event: Eye pain (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 13 affected / 125 at risk

Adverse event: Eye pain (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 30 affected / 125 at risk

Adverse event: Eye pruritus (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 5 affected / 125 at risk

Adverse event: Foreign body sensation in eyes (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 8 affected / 125 at risk

Adverse event: Lacrimation increased (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 15 affected / 125 at risk

Adverse event: Macular fibrosis (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 15 affected / 125 at risk

Adverse event: Macular fibrosis (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 17 affected / 125 at risk

Adverse event: Macular oedema (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 46 affected / 125 at risk

Adverse event: Macular oedema (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 29 affected / 125 at risk

Adverse event: Ocular hyperaemia (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 14 affected / 125 at risk

Adverse event: Photophobia (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 5 affected / 125 at risk

Adverse event: Posterior capsule opacification (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 4 affected / 125 at risk

Adverse event: Retinal aneurysm (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 6 affected / 125 at risk

Adverse event: Retinal aneurysm (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 6 affected / 125 at risk

Adverse event: Retinal exudates (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=study eye
Frequency: 15 affected / 125 at risk

Adverse event: Retinal exudates (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 24 affected / 125 at risk

Adverse event: Retinal haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 37 affected / 125 at risk

Adverse event: Retinal haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 20 affected / 125 at risk

Adverse event: Retinal neovascularisation (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 18 affected / 125 at risk

Adverse event: Retinal neovascularisation (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 6 affected / 125 at risk

Adverse event: Vision blurred (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 6 affected / 125 at risk

Adverse event: Vision blurred (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 11 affected / 125 at risk

Adverse event: Visual acuity reduced (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 7 affected / 125 at risk

Adverse event: Vitreous detachment (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 23 affected / 125 at risk

Adverse event: Vitreous detachment (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 20 affected / 125 at risk

Adverse event: Vitreous floaters (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 10 affected / 125 at risk

Adverse event: Vitreous floaters (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 20 affected / 125 at risk

Adverse event: Vitreous haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 10 affected / 125 at risk

Adverse event: Vitreous haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 6 affected / 125 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 125 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 125 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 125 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 125 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 125 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 13 affected / 125 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 125 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 7 affected / 125 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 125 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 125 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 125 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 125 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 125 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 125 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 125 at risk

Adverse event: Corneal abrasion (S)
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: (S)=study eye
Frequency: 4 affected / 125 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 125 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 125 at risk

Adverse event: Intraocular pressure increased (F)
Serious: no
Organ System: Investigations
Notes: (F)=fellow eye
Frequency: 8 affected / 125 at risk

Adverse event: Intraocular pressure increased (S)
Serious: no
Organ System: Investigations
Notes: (S)=study eye
Frequency: 20 affected / 125 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 125 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 125 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 125 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 125 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 125 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 125 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 125 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 125 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 125 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 125 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 125 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 125 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 125 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 125 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 125 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 125 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 125 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 125 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 30 affected / 125 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 125 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 76 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 76 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 76 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 76 at risk

Adverse event: Retinal haemorrhage (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 76 at risk

Adverse event: Retinal tear (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 76 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 76 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 76 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 76 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 76 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 76 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 76 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 76 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 76 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 76 at risk

Adverse event: Blindness (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 76 at risk

Adverse event: Ulcerative keratitis (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 76 at risk

Adverse event: Atrioventricular block second degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 76 at risk

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

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 76 at risk

Adverse event: Squamous cell carcinoma of lung
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 76 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 76 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 76 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 76 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 76 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 76 at risk

Adverse event: Blepharitis (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 76 at risk

Adverse event: Blepharitis (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 2 affected / 76 at risk

Adverse event: Cataract (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 3 affected / 76 at risk

Adverse event: Cataract (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 7 affected / 76 at risk

Adverse event: Cataract subcapsular (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 76 at risk

Adverse event: Conjunctival haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 8 affected / 76 at risk

Adverse event: Conjunctival haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 6 affected / 76 at risk

Adverse event: Diabetic retinal oedema (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 3 affected / 76 at risk

Adverse event: Diabetic retinal oedema (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 2 affected / 76 at risk

Adverse event: Diabetic retinopathy (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 3 affected / 76 at risk

Adverse event: Diabetic retinopathy (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 3 affected / 76 at risk

Adverse event: Dry eye (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 76 at risk

Adverse event: Dry eye (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 76 at risk

Adverse event: Eye irritation (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 2 affected / 76 at risk

Adverse event: Eye pain (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 3 affected / 76 at risk

Adverse event: Eye pain (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 3 affected / 76 at risk

Adverse event: Eye pruritus (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 2 affected / 76 at risk

Adverse event: Foreign body sensation in eyes (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 76 at risk

Adverse event: Lacrimation increased (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 76 at risk

Adverse event: Macular fibrosis (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 2 affected / 76 at risk

Adverse event: Macular fibrosis (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 2 affected / 76 at risk

Adverse event: Macular oedema (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 5 affected / 76 at risk

Adverse event: Macular oedema (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 3 affected / 76 at risk

Adverse event: Ocular hyperaemia (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 76 at risk

Adverse event: Retinal exudates (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=study eye
Frequency: 3 affected / 76 at risk

Adverse event: Retinal exudates (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 76 at risk

Adverse event: Retinal haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 4 affected / 76 at risk

Adverse event: Retinal haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 3 affected / 76 at risk

Adverse event: Retinal neovascularisation (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 2 affected / 76 at risk

Adverse event: Retinal neovascularisation (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 2 affected / 76 at risk

Adverse event: Vision blurred (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 76 at risk

Adverse event: Visual acuity reduced (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 76 at risk

Adverse event: Vitreous detachment (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 2 affected / 76 at risk

Adverse event: Vitreous detachment (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 76 at risk

Adverse event: Vitreous floaters (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 4 affected / 76 at risk

Adverse event: Vitreous floaters (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 2 affected / 76 at risk

Adverse event: Vitreous haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 76 at risk

Adverse event: Vitreous haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 76 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 76 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 76 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 76 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 76 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 76 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 76 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 76 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 76 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 76 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 76 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 76 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 76 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 76 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 76 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 76 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 76 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 76 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 76 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 76 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 76 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 76 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 76 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 76 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 76 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 76 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 76 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 76 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 76 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 76 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 90 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 90 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 90 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 90 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 90 at risk

Adverse event: Retinal detachment (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 90 at risk

Adverse event: Visual acuity reduced (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 90 at risk

Adverse event: Vitreous haemorrhage (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 90 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 90 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 90 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 90 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 90 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 90 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 90 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 90 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 90 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 90 at risk

Adverse event: Macular hole (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 90 at risk

Adverse event: Cardiomegaly
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 90 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 90 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 90 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 90 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 90 at risk

Adverse event: Neuropathic arthropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Ovarian neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 90 at risk

Adverse event: Ovarian cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 90 at risk

Adverse event: Embolic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Intraventricular haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Intracranial aneurysm
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Dysarthria
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 90 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Decubitus ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Corneal epithelium defect (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 90 at risk

Adverse event: Corneal oedema (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 90 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 90 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 90 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 90 at risk

Adverse event: Blepharitis (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 90 at risk

Adverse event: Blepharitis (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 90 at risk

Adverse event: Cataract (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 3 affected / 90 at risk

Adverse event: Cataract (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 4 affected / 90 at risk

Adverse event: Cataract nuclear (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 3 affected / 90 at risk

Adverse event: Cataract nuclear (S)
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 3 affected / 90 at risk

Adverse event: Cataract subcapsular (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 4 affected / 90 at risk

Adverse event: Conjunctival haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 11 affected / 90 at risk

Adverse event: Conjunctival haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 13 affected / 90 at risk

Adverse event: Cystoid macular oedema (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 2 affected / 90 at risk

Adverse event: Cystoid macular oedema (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 4 affected / 90 at risk

Adverse event: Diabetic retinal oedema (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 5 affected / 90 at risk

Adverse event: Diabetic retinal oedema (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 7 affected / 90 at risk

Adverse event: Diabetic retinopathy (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 3 affected / 90 at risk

Adverse event: Diabetic retinopathy (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 90 at risk

Adverse event: Dry eye (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 90 at risk

Adverse event: Dry eye (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 3 affected / 90 at risk

Adverse event: Eye irritation (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 3 affected / 90 at risk

Adverse event: Eye pain (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 7 affected / 90 at risk

Adverse event: Eye pain (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 5 affected / 90 at risk

Adverse event: Eye pruritus (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 3 affected / 90 at risk

Adverse event: Foreign body sensation in eyes (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 3 affected / 90 at risk

Adverse event: Macular fibrosis (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 90 at risk

Adverse event: Macular oedema (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 9 affected / 90 at risk

Adverse event: Macular oedema (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 9 affected / 90 at risk

Adverse event: Ocular hyperaemia (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 2 affected / 90 at risk

Adverse event: Posterior capsule opacification (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 90 at risk

Adverse event: Retinal aneurysm (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 90 at risk

Adverse event: Retinal aneurysm (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 90 at risk

Adverse event: Retinal exudates (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=study eye
Frequency: 1 affected / 90 at risk

Adverse event: Retinal exudates (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 4 affected / 90 at risk

Adverse event: Retinal haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 3 affected / 90 at risk

Adverse event: Retinal haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 3 affected / 90 at risk

Adverse event: Retinal neovascularisation (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 2 affected / 90 at risk

Adverse event: Retinal neovascularisation (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 3 affected / 90 at risk

Adverse event: Vision blurred (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 2 affected / 90 at risk

Adverse event: Vision blurred (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 4 affected / 90 at risk

Adverse event: Visual acuity reduced (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 90 at risk

Adverse event: Vitreous detachment (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 2 affected / 90 at risk

Adverse event: Vitreous floaters (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 7 affected / 90 at risk

Adverse event: Vitreous floaters (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 6 affected / 90 at risk

Adverse event: Vitreous haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 5 affected / 90 at risk

Adverse event: Vitreous haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 2 affected / 90 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 90 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 90 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 90 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 90 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 90 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 90 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 6 affected / 90 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 90 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 90 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 90 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 90 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 90 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 90 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 90 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 90 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 90 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 90 at risk

Adverse event: Intraocular pressure increased (S)
Serious: no
Organ System: Investigations
Notes: (S)=study eye
Frequency: 5 affected / 90 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 90 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 90 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 90 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 90 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 90 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 90 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 90 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 90 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 90 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 90 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 90 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 90 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 90 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 90 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 90 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 90 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 79 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 79 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 79 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 79 at risk

Adverse event: Visual acuity reduced (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 79 at risk

Adverse event: Vitreous haemorrhage (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 79 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 79 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 79 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 79 at risk

Adverse event: Clostridial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 79 at risk

Adverse event: Diabetic foot infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 79 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 79 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 79 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 79 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 79 at risk

Adverse event: Blood glucose increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 79 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 79 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 79 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 79 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 79 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 79 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 79 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 79 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 79 at risk

Adverse event: Intra-ocular injection (S)
Serious: yes
Organ System: Surgical and medical procedures
Notes: (S)=study eye
Frequency: 1 affected / 79 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 79 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 79 at risk

Adverse event: Postoperative abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 79 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 79 at risk

Adverse event: Hyponatraemic syndrome
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 79 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 79 at risk

Adverse event: Crystal arthropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 79 at risk

Adverse event: Status epilepticus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 79 at risk

Adverse event: Decubitus ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 79 at risk

Adverse event: Haemorrhagic arteriovenous malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 79 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 79 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 79 at risk

Adverse event: Blepharitis (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 79 at risk

Adverse event: Blepharitis (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 79 at risk

Adverse event: Cataract (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 2 affected / 79 at risk

Adverse event: Cataract (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 2 affected / 79 at risk

Adverse event: Cataract cortical (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 79 at risk

Adverse event: Cataract nuclear (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 79 at risk

Adverse event: Cataract nuclear (S)
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 79 at risk

Adverse event: Conjunctival haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 9 affected / 79 at risk

Adverse event: Conjunctival haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 12 affected / 79 at risk

Adverse event: Cystoid macular oedema (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 2 affected / 79 at risk

Adverse event: Diabetic retinal oedema (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 5 affected / 79 at risk

Adverse event: Diabetic retinal oedema (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 4 affected / 79 at risk

Adverse event: Diabetic retinopathy (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 79 at risk

Adverse event: Dry eye (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 3 affected / 79 at risk

Adverse event: Dry eye (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 3 affected / 79 at risk

Adverse event: Eye irritation (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 6 affected / 79 at risk

Adverse event: Eye pain (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 5 affected / 79 at risk

Adverse event: Eye pain (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 7 affected / 79 at risk

Adverse event: Eye pruritus (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 2 affected / 79 at risk

Adverse event: Foreign body sensation in eyes (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 79 at risk

Adverse event: Lacrimation increased (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 79 at risk

Adverse event: Macular fibrosis (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 2 affected / 79 at risk

Adverse event: Macular fibrosis (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 79 at risk

Adverse event: Macular oedema (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 11 affected / 79 at risk

Adverse event: Macular oedema (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 8 affected / 79 at risk

Adverse event: Ocular hyperaemia (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 2 affected / 79 at risk

Adverse event: Posterior capsule opacification (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 3 affected / 79 at risk

Adverse event: Retinal aneurysm (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 79 at risk

Adverse event: Retinal aneurysm (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 79 at risk

Adverse event: Retinal exudates (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 2 affected / 79 at risk

Adverse event: Retinal haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 3 affected / 79 at risk

Adverse event: Retinal haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 5 affected / 79 at risk

Adverse event: Retinal neovascularisation (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 79 at risk

Adverse event: Retinal neovascularisation (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 79 at risk

Adverse event: Vision blurred (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 79 at risk

Adverse event: Vision blurred (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 2 affected / 79 at risk

Adverse event: Visual acuity reduced (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 79 at risk

Adverse event: Vitreous detachment (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 2 affected / 79 at risk

Adverse event: Vitreous detachment (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 3 affected / 79 at risk

Adverse event: Vitreous floaters (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 2 affected / 79 at risk

Adverse event: Vitreous floaters (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 4 affected / 79 at risk

Adverse event: Vitreous haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 79 at risk

Adverse event: Vitreous haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 2 affected / 79 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 79 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 79 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 79 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 79 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 79 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 79 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 79 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 79 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 79 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 79 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 79 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 79 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 79 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 79 at risk

Adverse event: Corneal abrasion (S)
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: (S)=study eye
Frequency: 1 affected / 79 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 79 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 79 at risk

Adverse event: Intraocular pressure increased (F)
Serious: no
Organ System: Investigations
Notes: (F)=fellow eye
Frequency: 2 affected / 79 at risk

Adverse event: Intraocular pressure increased (S)
Serious: no
Organ System: Investigations
Notes: (S)=study eye
Frequency: 2 affected / 79 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 79 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 79 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 79 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 79 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 79 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 79 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 79 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 79 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 79 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 79 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 79 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 79 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 79 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 79 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 79 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 79 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 79 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 79 at risk