Study: NCT00473382

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 127 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 127 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 127 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 127 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 127 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 127 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 127 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 127 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 127 at risk

Adverse event: Graves' disease
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 127 at risk

Adverse event: Macular ischaemia (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 127 at risk

Adverse event: Retinal detachment (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 127 at risk

Adverse event: Retinal haemorrhage (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 127 at risk

Adverse event: Visual acuity reduced (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 2 affected / 127 at risk

Adverse event: Vitreous haemorrhage (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 2 affected / 127 at risk

Adverse event: Appendiceal mucocoele
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 127 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 127 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 127 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 127 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 127 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 127 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 127 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 127 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Empyema
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 127 at risk

Adverse event: Pneumonia mycoplasmal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 127 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 127 at risk

Adverse event: Product administration error
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 127 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 127 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 127 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 127 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 127 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 127 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 127 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 127 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 127 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 127 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 127 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 127 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 127 at risk

Adverse event: Spondylolisthesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 127 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 127 at risk

Adverse event: Non-Hodgkin's lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 127 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 127 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 127 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 127 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 127 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 127 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 127 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 127 at risk

Adverse event: Facial paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 127 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 127 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 127 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 127 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 127 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 127 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 127 at risk

Adverse event: Respiratory tract congestion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 127 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 127 at risk

Adverse event: Vitreous haemorrhage (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 3 affected / 127 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 127 at risk

Adverse event: Atrioventricular block second degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 127 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 127 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 127 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 127 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 127 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 127 at risk

Adverse event: Cataract (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 29 affected / 127 at risk

Adverse event: Cataract (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 35 affected / 127 at risk

Adverse event: Cataract cortical (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 5 affected / 127 at risk

Adverse event: Cataract cortical (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 5 affected / 127 at risk

Adverse event: Cataract nuclear (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 127 at risk

Adverse event: Cataract nuclear (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 3 affected / 127 at risk

Adverse event: Cataract subcapsular (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 3 affected / 127 at risk

Adverse event: Conjunctival haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 3 affected / 127 at risk

Adverse event: Conjunctival haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 40 affected / 127 at risk

Adverse event: Diabetic retinal oedema (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 19 affected / 127 at risk

Adverse event: Diabetic retinal oedema (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 8 affected / 127 at risk

Adverse event: Diabetic retinopathy (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 5 affected / 127 at risk

Adverse event: Dry eye (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 8 affected / 127 at risk

Adverse event: Dry eye (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 6 affected / 127 at risk

Adverse event: Eye irritation (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 4 affected / 127 at risk

Adverse event: Eye pain (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 10 affected / 127 at risk

Adverse event: Foreign body sensation in eyes (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 7 affected / 127 at risk

Adverse event: Lacrimation increased (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 4 affected / 127 at risk

Adverse event: Macular fibrosis (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 5 affected / 127 at risk

Adverse event: Macular fibrosis (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 11 affected / 127 at risk

Adverse event: Macular oedema (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 28 affected / 127 at risk

Adverse event: Macular oedema (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 26 affected / 127 at risk

Adverse event: Ocular hyperaemia (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 10 affected / 127 at risk

Adverse event: Posterior capsule opacification (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 4 affected / 127 at risk

Adverse event: Retinal exudates (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 16 affected / 127 at risk

Adverse event: Retinal exudates (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 15 affected / 127 at risk

Adverse event: Retinal haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 20 affected / 127 at risk

Adverse event: Retinal haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 22 affected / 127 at risk

Adverse event: Retinal neovascularisation (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 10 affected / 127 at risk

Adverse event: Retinal neovascularisation (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 7 affected / 127 at risk

Adverse event: Vision blurred (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 5 affected / 127 at risk

Adverse event: Vitreous detachment (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 19 affected / 127 at risk

Adverse event: Vitreous detachment (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 19 affected / 127 at risk

Adverse event: Vitreous floaters (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 7 affected / 127 at risk

Adverse event: Vitreous floaters (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 4 affected / 127 at risk

Adverse event: Vitreous haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 12 affected / 127 at risk

Adverse event: Vitreous haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 16 affected / 127 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 127 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 127 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 127 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 127 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 127 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 4 affected / 127 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 127 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 5 affected / 127 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 127 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 127 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 127 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 127 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 127 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 127 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 127 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 127 at risk

Adverse event: Corneal abrasion (S)
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: (S)=study eye
Frequency: 6 affected / 127 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 127 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 127 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 127 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 127 at risk

Adverse event: Intraocular pressure increased (F)
Serious: no
Organ System: Investigations
Notes: (F)=fellow eye
Frequency: 6 affected / 127 at risk

Adverse event: Intraocular pressure increased (S)
Serious: no
Organ System: Investigations
Notes: (S)=study eye
Frequency: 14 affected / 127 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 127 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 127 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 127 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 127 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 127 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 127 at risk

Adverse event: Diabetic neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 127 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 127 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 127 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 127 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 127 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 127 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 127 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 127 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 31 affected / 127 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 127 at risk

Adverse event: Blood urea increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 127 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 127 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 127 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 127 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 127 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 127 at risk

Adverse event: Arteriosclerosis coronary artery
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 127 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 127 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 127 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 127 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 127 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 127 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 127 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 127 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 127 at risk

Adverse event: Graves' disease
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 127 at risk

Adverse event: Macular ischaemia (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 127 at risk

Adverse event: Retinal detachment (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 127 at risk

Adverse event: Retinal haemorrhage (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 127 at risk

Adverse event: Visual acuity reduced (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 2 affected / 127 at risk

Adverse event: Vitreous haemorrhage (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 3 affected / 127 at risk

Adverse event: Appendiceal mucocoele
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 127 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 127 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 127 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 127 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 127 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 127 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 127 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 127 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 127 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 127 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 127 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Empyema
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 127 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 127 at risk

Adverse event: Pneumonia mycoplasmal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 127 at risk

Adverse event: Corneal abrasion (S)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: (S)=study eye
Frequency: 1 affected / 127 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 127 at risk

Adverse event: Product administration error
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 127 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 127 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 127 at risk

Adverse event: Post procedural complication (S)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: (S)=study eye
Frequency: 1 affected / 127 at risk

Adverse event: Postoperative ileus
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 127 at risk

Adverse event: Procedural complication (S)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: (S)=study eye
Frequency: 1 affected / 127 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 127 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 127 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 127 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 127 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 127 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 127 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 127 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 127 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 127 at risk

Adverse event: Groin pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 127 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 127 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 127 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 127 at risk

Adverse event: Spondylolisthesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 127 at risk

Adverse event: Bladder papilloma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 127 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 127 at risk

Adverse event: Non-Hodgkin's lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 127 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 127 at risk

Adverse event: Renal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 127 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 127 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 127 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 127 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 127 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 127 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 127 at risk

Adverse event: Facial paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 127 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 127 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 127 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 127 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 127 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 127 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 127 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 127 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 127 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 127 at risk

Adverse event: Respiratory tract congestion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 127 at risk

Adverse event: Nephroureterectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 127 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 127 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 127 at risk

Adverse event: Vascular insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 127 at risk

Adverse event: Vitreous haemorrhage (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 4 affected / 127 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 127 at risk

Adverse event: Atrioventricular block second degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 127 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 127 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 127 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 127 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 127 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 127 at risk

Adverse event: Cataract (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 32 affected / 127 at risk

Adverse event: Cataract (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 39 affected / 127 at risk

Adverse event: Cataract cortical (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 8 affected / 127 at risk

Adverse event: Cataract cortical (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 6 affected / 127 at risk

Adverse event: Cataract nuclear (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 2 affected / 127 at risk

Adverse event: Cataract nuclear (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 4 affected / 127 at risk

Adverse event: Cataract subcapsular (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 3 affected / 127 at risk

Adverse event: Conjunctival haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 11 affected / 127 at risk

Adverse event: Conjunctival haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 45 affected / 127 at risk

Adverse event: Diabetic retinal oedema (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 20 affected / 127 at risk

Adverse event: Diabetic retinal oedema (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 8 affected / 127 at risk

Adverse event: Diabetic retinopathy (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 5 affected / 127 at risk

Adverse event: Dry eye (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 10 affected / 127 at risk

Adverse event: Dry eye (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 8 affected / 127 at risk

Adverse event: Eye irritation (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 6 affected / 127 at risk

Adverse event: Eye pain (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 12 affected / 127 at risk

Adverse event: Foreign body sensation in eyes (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 8 affected / 127 at risk

Adverse event: Lacrimation increased (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 6 affected / 127 at risk

Adverse event: Macular fibrosis (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 6 affected / 127 at risk

Adverse event: Macular fibrosis (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 14 affected / 127 at risk

Adverse event: Macular oedema (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 37 affected / 127 at risk

Adverse event: Macular oedema (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 33 affected / 127 at risk

Adverse event: Ocular hyperaemia (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 10 affected / 127 at risk

Adverse event: Posterior capsule opacification (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 6 affected / 127 at risk

Adverse event: Retinal exudates (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 18 affected / 127 at risk

Adverse event: Retinal exudates (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 19 affected / 127 at risk

Adverse event: Retinal haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 31 affected / 127 at risk

Adverse event: Retinal haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 26 affected / 127 at risk

Adverse event: Retinal neovascularisation (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 13 affected / 127 at risk

Adverse event: Retinal neovascularisation (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 8 affected / 127 at risk

Adverse event: Vision blurred (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 5 affected / 127 at risk

Adverse event: Vitreous detachment (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 20 affected / 127 at risk

Adverse event: Vitreous detachment (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 22 affected / 127 at risk

Adverse event: Vitreous floaters (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 8 affected / 127 at risk

Adverse event: Vitreous floaters (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 6 affected / 127 at risk

Adverse event: Vitreous haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 16 affected / 127 at risk

Adverse event: Vitreous haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 17 affected / 127 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 127 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 127 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 127 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 127 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 127 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 4 affected / 127 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 7 affected / 127 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 127 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 127 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 127 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 127 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 127 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 127 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 127 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 127 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 127 at risk

Adverse event: Corneal abrasion (S)
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: (S)=study eye
Frequency: 8 affected / 127 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 127 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 127 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 127 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 127 at risk

Adverse event: Intraocular pressure increased (F)
Serious: no
Organ System: Investigations
Notes: (F)=fellow eye
Frequency: 7 affected / 127 at risk

Adverse event: Intraocular pressure increased (S)
Serious: no
Organ System: Investigations
Notes: (S)=study eye
Frequency: 17 affected / 127 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 25 affected / 127 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 127 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 127 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 127 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 127 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 127 at risk

Adverse event: Diabetic neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 127 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 127 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 127 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 127 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 127 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 127 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 127 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 127 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 35 affected / 127 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 7 affected / 127 at risk

Adverse event: Blood urea increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 127 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 125 at risk

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

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 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 acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 125 at risk

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

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

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 125 at risk

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

Adverse event: Cardiac ventricular thrombosis
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: Deafness
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 125 at risk

Adverse event: Goitre
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 125 at risk

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

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

Adverse event: Vitreous haemorrhage (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 10 affected / 125 at risk

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

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

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

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 125 at risk

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

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

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

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

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 125 at risk

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

Adverse event: Endophthalmitis (S)
Serious: yes
Organ System: Infections and infestations
Notes: (S)=study eye
Frequency: 3 affected / 125 at risk

Adverse event: Escherichia sepsis
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: Osteomyelitis
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: Pseudomonal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 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: Head injury
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: Medication error (S)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: (S)=study eye
Frequency: 1 affected / 125 at risk

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

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
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: Diabetic ketoacidosis
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: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 125 at risk

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

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

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

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

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

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

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

Adverse event: Diabetic nephropathy
Serious: yes
Organ System: Renal and urinary 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 failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 125 at risk

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

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

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

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

Adverse event: Pulmonary hypertension
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: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 125 at risk

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

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

Adverse event: Aortic aneurysm rupture
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: 2 affected / 125 at risk

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

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

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 125 at risk

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

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

Adverse event: Bronchitis
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: 13 affected / 125 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 125 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 125 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 125 at risk

Adverse event: Cataract (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 38 affected / 125 at risk

Adverse event: Cataract (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 31 affected / 125 at risk

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

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

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

Adverse event: Conjunctival haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 8 affected / 125 at risk

Adverse event: Conjunctival haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 54 affected / 125 at risk

Adverse event: Diabetic retinal oedema (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 25 affected / 125 at risk

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

Adverse event: Diabetic retinopathy (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 8 affected / 125 at risk

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

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

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

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

Adverse event: Foreign body sensation in eyes (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 10 affected / 125 at risk

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

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

Adverse event: Macular fibrosis (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 7 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: 32 affected / 125 at risk

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

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

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

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

Adverse event: Retinal haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 32 affected / 125 at risk

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

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

Adverse event: Retinal neovascularisation (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 125 at risk

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

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

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

Adverse event: Vitreous floaters (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 3 affected / 125 at risk

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

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

Adverse event: Vitreous haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 3 affected / 125 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 125 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 125 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 125 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 125 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 125 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 9 affected / 125 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 125 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 12 affected / 125 at risk

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

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 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: 16 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: 9 affected / 125 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 125 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 125 at risk

Adverse event: Corneal abrasion (S)
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: (S)=study eye
Frequency: 7 affected / 125 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 125 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 125 at risk

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

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 10 affected / 125 at risk

Adverse event: Intraocular pressure increased (F)
Serious: no
Organ System: Investigations
Notes: (F)=fellow eye
Frequency: 7 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: 19 affected / 125 at risk

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

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

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 125 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 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: Diabetic neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 125 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 125 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 125 at risk

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

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 125 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 125 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 125 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 125 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 33 affected / 125 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 125 at risk

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

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

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

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

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

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

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

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

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

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

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 124 at risk

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

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

Adverse event: Hypothyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 124 at risk

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

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

Adverse event: Cataract (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 3 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: Corneal opacity (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 124 at risk

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

Adverse event: Macular ischaemia (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: Papilloedema (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: 2 affected / 124 at risk

Adverse event: Vitreous haemorrhage (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 4 affected / 124 at risk

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

Adverse event: Gastric 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: Pancreatitis acute
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: Biliary obstruction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 124 at risk

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

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

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

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

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

Adverse event: Endophthalmitis (S)
Serious: yes
Organ System: Infections and infestations
Notes: (S)=study eye
Frequency: 2 affected / 124 at risk

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

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

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

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

Adverse event: Kidney infection
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: 1 affected / 124 at risk

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

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 124 at risk

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

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

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

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

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

Adverse event: Cataract traumatic (S)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: (S)=study eye
Frequency: 1 affected / 124 at risk

Adverse event: Corneal abrasion (S)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: (S)=study eye
Frequency: 1 affected / 124 at risk

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

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

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

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

Adverse event: Intraocular pressure increased (S)
Serious: yes
Organ System: Investigations
Notes: (S)=study eye
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
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 124 at risk

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 124 at risk

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

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

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

Adverse event: Parkinson's disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 124 at risk

Adverse event: Presyncope
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: 1 affected / 124 at risk

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

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

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 124 at risk

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

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 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: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 124 at risk

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

Adverse event: Respiratory failure
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: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 124 at risk

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

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 124 at risk

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

Adverse event: Orthostatic 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: 2 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: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 124 at risk

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

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

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

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 22 affected / 124 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 124 at risk

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

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 124 at risk

Adverse event: Cataract (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 41 affected / 124 at risk

Adverse event: Cataract (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 35 affected / 124 at risk

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

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

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

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

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

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

Adverse event: Conjunctival haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 63 affected / 124 at risk

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

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

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

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

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

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

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

Adverse event: Foreign body sensation in eyes (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 4 affected / 124 at risk

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

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

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

Adverse event: Macular oedema (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 53 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: 5 affected / 124 at risk

Adverse event: Posterior capsule opacification (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 5 affected / 124 at risk

Adverse event: Retinal exudates (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 21 affected / 124 at risk

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

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

Adverse event: Retinal haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 34 affected / 124 at risk

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

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

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

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

Adverse event: Vitreous detachment (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 23 affected / 124 at risk

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

Adverse event: Vitreous floaters (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 13 affected / 124 at risk

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

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

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 124 at risk

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

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 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: 8 affected / 124 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 124 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 9 affected / 124 at risk

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

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 124 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 13 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: 14 affected / 124 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 124 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 124 at risk

Adverse event: Corneal abrasion (S)
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: (S)=study eye
Frequency: 4 affected / 124 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 124 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 124 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 124 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 124 at risk

Adverse event: Intraocular pressure increased (F)
Serious: no
Organ System: Investigations
Notes: (F)=fellow eye
Frequency: 12 affected / 124 at risk

Adverse event: Intraocular pressure increased (S)
Serious: no
Organ System: Investigations
Notes: (S)=study eye
Frequency: 25 affected / 124 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 124 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 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: 6 affected / 124 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 124 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 124 at risk

Adverse event: Diabetic neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 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: 7 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: 3 affected / 124 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 124 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 124 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 38 affected / 124 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 124 at risk

Adverse event: Blood urea increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 124 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 88 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 88 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 88 at risk

Adverse event: Visual acuity reduced (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 88 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 88 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 88 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 88 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 88 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 88 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 88 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 88 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 88 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 88 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 88 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 88 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 88 at risk

Adverse event: Escherichia infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Diabetic foot infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Joint swelling
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 88 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 88 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 88 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 88 at risk

Adverse event: Cataract (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 5 affected / 88 at risk

Adverse event: Cataract (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 5 affected / 88 at risk

Adverse event: Cataract cortical (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 3 affected / 88 at risk

Adverse event: Cataract nuclear (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 88 at risk

Adverse event: Conjunctival haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 3 affected / 88 at risk

Adverse event: Conjunctival haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 7 affected / 88 at risk

Adverse event: Diabetic retinal oedema (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 2 affected / 88 at risk

Adverse event: Diabetic retinal oedema (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 88 at risk

Adverse event: Dry eye (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 5 affected / 88 at risk

Adverse event: Dry eye (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 4 affected / 88 at risk

Adverse event: Eye irritation (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 88 at risk

Adverse event: Foreign body sensation in eyes (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 88 at risk

Adverse event: Macular fibrosis (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 88 at risk

Adverse event: Macular fibrosis (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 4 affected / 88 at risk

Adverse event: Macular oedema (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 10 affected / 88 at risk

Adverse event: Macular oedema (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 9 affected / 88 at risk

Adverse event: Retinal exudates (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 2 affected / 88 at risk

Adverse event: Retinal haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 6 affected / 88 at risk

Adverse event: Retinal haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 4 affected / 88 at risk

Adverse event: Retinal neovascularisation (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 3 affected / 88 at risk

Adverse event: Vision blurred (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 88 at risk

Adverse event: Vitreous detachment (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 88 at risk

Adverse event: Vitreous detachment (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 2 affected / 88 at risk

Adverse event: Vitreous floaters (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 2 affected / 88 at risk

Adverse event: Vitreous floaters (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 4 affected / 88 at risk

Adverse event: Vitreous haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 5 affected / 88 at risk

Adverse event: Vitreous haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 2 affected / 88 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 88 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 88 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 88 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 4 affected / 88 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 88 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 88 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 88 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 88 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 88 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 88 at risk

Adverse event: Corneal abrasion (S)
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: (S)=study eye
Frequency: 1 affected / 88 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 88 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 88 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 88 at risk

Adverse event: Intraocular pressure increased (F)
Serious: no
Organ System: Investigations
Notes: (F)=fellow eye
Frequency: 2 affected / 88 at risk

Adverse event: Intraocular pressure increased (S)
Serious: no
Organ System: Investigations
Notes: (S)=study eye
Frequency: 2 affected / 88 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 88 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 88 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 88 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 88 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 88 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 88 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 88 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 88 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 88 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 88 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 88 at risk

Adverse event: Blood urea increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 88 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 83 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 83 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 83 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 83 at risk

Adverse event: Visual acuity reduced (F)
Serious: yes
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 83 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 83 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 83 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 83 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 83 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 83 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 83 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 83 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 83 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 83 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 83 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 83 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 83 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 83 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 83 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 83 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 83 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 83 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 83 at risk

Adverse event: Vitreous haemorrhage (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 83 at risk

Adverse event: Retinal detachment (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 2 affected / 83 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 83 at risk

Adverse event: Atrioventricular block second degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 83 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Abdominal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 83 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 83 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 83 at risk

Adverse event: Neck injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 83 at risk

Adverse event: Skull fractured base
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 83 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 83 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 83 at risk

Adverse event: Endometrial cancer stage I
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 83 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 83 at risk

Adverse event: Hypoglycaemic coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 83 at risk

Adverse event: Stent placement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 83 at risk

Adverse event: Arteriosclerosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 83 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 83 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 83 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 83 at risk

Adverse event: Cataract (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 83 at risk

Adverse event: Cataract (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 6 affected / 83 at risk

Adverse event: Cataract cortical (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 83 at risk

Adverse event: Cataract cortical (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 2 affected / 83 at risk

Adverse event: Cataract nuclear (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 83 at risk

Adverse event: Cataract nuclear (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 83 at risk

Adverse event: Cataract subcapsular (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 83 at risk

Adverse event: Conjunctival haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 2 affected / 83 at risk

Adverse event: Conjunctival haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 4 affected / 83 at risk

Adverse event: Diabetic retinal oedema (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 83 at risk

Adverse event: Diabetic retinopathy (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 2 affected / 83 at risk

Adverse event: Dry eye (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 2 affected / 83 at risk

Adverse event: Dry eye (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 3 affected / 83 at risk

Adverse event: Eye irritation (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 83 at risk

Adverse event: Eye pain (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 3 affected / 83 at risk

Adverse event: Foreign body sensation in eyes (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 83 at risk

Adverse event: Lacrimation increased (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 83 at risk

Adverse event: Macular fibrosis (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 83 at risk

Adverse event: Macular fibrosis (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 83 at risk

Adverse event: Macular oedema (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 8 affected / 83 at risk

Adverse event: Macular oedema (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 6 affected / 83 at risk

Adverse event: Ocular hyperaemia (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 83 at risk

Adverse event: Posterior capsule opacification (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 83 at risk

Adverse event: Retinal exudates (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 2 affected / 83 at risk

Adverse event: Retinal exudates (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 3 affected / 83 at risk

Adverse event: Retinal haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 9 affected / 83 at risk

Adverse event: Retinal haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 9 affected / 83 at risk

Adverse event: Retinal neovascularisation (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 83 at risk

Adverse event: Retinal neovascularisation (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 83 at risk

Adverse event: Vision blurred (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 2 affected / 83 at risk

Adverse event: Vitreous detachment (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 3 affected / 83 at risk

Adverse event: Vitreous detachment (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 2 affected / 83 at risk

Adverse event: Vitreous floaters (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 3 affected / 83 at risk

Adverse event: Vitreous floaters (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 83 at risk

Adverse event: Vitreous haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 4 affected / 83 at risk

Adverse event: Vitreous haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 3 affected / 83 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 83 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 83 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 83 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 83 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 83 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 83 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 83 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 83 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 83 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 83 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 83 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 83 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 83 at risk

Adverse event: Intraocular pressure increased (F)
Serious: no
Organ System: Investigations
Notes: (F)=fellow eye
Frequency: 1 affected / 83 at risk

Adverse event: Intraocular pressure increased (S)
Serious: no
Organ System: Investigations
Notes: (S)=study eye
Frequency: 2 affected / 83 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 83 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 83 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 83 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 83 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 83 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 83 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 83 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 83 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 83 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 83 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 83 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 84 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 84 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 84 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 84 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 84 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 84 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 84 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 84 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 84 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 84 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 84 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 84 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Vitreous haemorrhage (S)
Serious: yes
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 84 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 84 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 84 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 84 at risk

Adverse event: Pneumonia fungal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Endocarditis staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 84 at risk

Adverse event: Pelvic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 84 at risk

Adverse event: Hepatic cancer recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 84 at risk

Adverse event: Myeloid leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 84 at risk

Adverse event: Hypoglycaemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 84 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 84 at risk

Adverse event: Retinal vein occlusion (F)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 84 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 84 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 84 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 84 at risk

Adverse event: Cataract (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 3 affected / 84 at risk

Adverse event: Cataract (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 5 affected / 84 at risk

Adverse event: Cataract cortical (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 84 at risk

Adverse event: Cataract nuclear (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 84 at risk

Adverse event: Conjunctival haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 5 affected / 84 at risk

Adverse event: Conjunctival haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 6 affected / 84 at risk

Adverse event: Diabetic retinal oedema (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 84 at risk

Adverse event: Diabetic retinal oedema (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 3 affected / 84 at risk

Adverse event: Dry eye (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 84 at risk

Adverse event: Dry eye (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 84 at risk

Adverse event: Eye irritation (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 2 affected / 84 at risk

Adverse event: Eye pain (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 84 at risk

Adverse event: Foreign body sensation in eyes (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 84 at risk

Adverse event: Macular fibrosis (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 84 at risk

Adverse event: Macular fibrosis (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 3 affected / 84 at risk

Adverse event: Macular oedema (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 9 affected / 84 at risk

Adverse event: Macular oedema (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 9 affected / 84 at risk

Adverse event: Ocular hyperaemia (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 84 at risk

Adverse event: Posterior capsule opacification (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 84 at risk

Adverse event: Retinal exudates (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 84 at risk

Adverse event: Retinal exudates (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 4 affected / 84 at risk

Adverse event: Retinal haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 8 affected / 84 at risk

Adverse event: Retinal haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 7 affected / 84 at risk

Adverse event: Retinal neovascularisation (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 3 affected / 84 at risk

Adverse event: Retinal neovascularisation (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 84 at risk

Adverse event: Vitreous detachment (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 1 affected / 84 at risk

Adverse event: Vitreous detachment (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 84 at risk

Adverse event: Vitreous floaters (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 4 affected / 84 at risk

Adverse event: Vitreous floaters (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 3 affected / 84 at risk

Adverse event: Vitreous haemorrhage (F)
Serious: no
Organ System: Eye disorders
Notes: (F)=fellow eye
Frequency: 3 affected / 84 at risk

Adverse event: Vitreous haemorrhage (S)
Serious: no
Organ System: Eye disorders
Notes: (S)=study eye
Frequency: 1 affected / 84 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 84 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 84 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 84 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 84 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 84 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 84 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 84 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 84 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 84 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 84 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 84 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 84 at risk

Adverse event: Intraocular pressure increased (F)
Serious: no
Organ System: Investigations
Notes: (F)=fellow eye
Frequency: 1 affected / 84 at risk

Adverse event: Intraocular pressure increased (S)
Serious: no
Organ System: Investigations
Notes: (S)=study eye
Frequency: 3 affected / 84 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 84 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 84 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 84 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 84 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 84 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 84 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 84 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 84 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 84 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 84 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 84 at risk