Study: NCT01535261

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 357 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 357 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 357 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 357 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 357 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 357 at risk

Adverse event: Cardiopulmonary failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 357 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 357 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 357 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 357 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 357 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 357 at risk

Adverse event: Cataract (Fellow untreated eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 357 at risk

Adverse event: Cataract (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 357 at risk

Adverse event: Glaucoma (Fellow untreated eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 357 at risk

Adverse event: Glaucoma (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 357 at risk

Adverse event: Hyphaema (Fellow untreated eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 357 at risk

Adverse event: Hyphaema (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 357 at risk

Adverse event: Myopia (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 357 at risk

Adverse event: Retinal haemorrhage (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 357 at risk

Adverse event: Retinal ischaemia (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 357 at risk

Adverse event: Retinal vascular thrombosis (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 357 at risk

Adverse event: Visual acuity reduced (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 357 at risk

Adverse event: Vitreous haemorrhage (Fellow untreated eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 357 at risk

Adverse event: Vitreous haemorrhage (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 357 at risk

Adverse event: Abdominal adhesions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 357 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 357 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 357 at risk

Adverse event: Diverticular perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 357 at risk

Adverse event: Duodenal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 357 at risk

Adverse event: Gastrointestinal polyp haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 357 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 357 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 357 at risk

Adverse event: Large intestine polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 357 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 357 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 357 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 357 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 357 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 357 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 357 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 357 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 357 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 357 at risk

Adverse event: Febrile infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 357 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 357 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 357 at risk

Adverse event: Ophthalmic herpes zoster (Fellow untreated eye)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 357 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 357 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 357 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 357 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 357 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 357 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 357 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 357 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 357 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 357 at risk

Adverse event: Limb traumatic amputation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 357 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 357 at risk

Adverse event: Scapula fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 357 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 357 at risk

Adverse event: Intraocular pressure increased (Study eye)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 357 at risk

Adverse event: Visual acuity tests abnormal (Study eye)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 357 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 357 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 357 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 357 at risk

Adverse event: Gouty arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 357 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 357 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 357 at risk

Adverse event: Bladder transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 357 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 357 at risk

Adverse event: Cholangiocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 357 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 357 at risk

Adverse event: Renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 357 at risk

Adverse event: Brain hypoxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 357 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 357 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 357 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 357 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 357 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 357 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 357 at risk

Adverse event: Renal mass
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 357 at risk

Adverse event: Haemorrhagic ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 357 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 357 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 357 at risk

Adverse event: Aneurysm ruptured
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 357 at risk

Adverse event: Angiopathy
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 357 at risk

Adverse event: Diabetic vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 357 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 357 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 357 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 357 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 357 at risk

Adverse event: Peripheral artery aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 357 at risk

Adverse event: Blepharitis (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 357 at risk

Adverse event: Cataract (Fellow untreated eye)
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 357 at risk

Adverse event: Cataract (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 15 affected / 357 at risk

Adverse event: Conjunctival haemorrhage (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 24 affected / 357 at risk

Adverse event: Dry eye (Fellow untreated eye)
Serious: no
Organ System: Eye disorders
Frequency: 19 affected / 357 at risk

Adverse event: Dry eye (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 22 affected / 357 at risk

Adverse event: Eye pain (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 25 affected / 357 at risk

Adverse event: Eyelid oedema (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 357 at risk

Adverse event: Glaucoma (Fellow untreated eye)
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 357 at risk

Adverse event: Glaucoma (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 357 at risk

Adverse event: Macular fibrosis (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 15 affected / 357 at risk

Adverse event: Macular oedema (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 19 affected / 357 at risk

Adverse event: Ocular discomfort (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 357 at risk

Adverse event: Ocular hyperaemia (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 357 at risk

Adverse event: Ocular hypertension (Fellow untreated eye)
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 357 at risk

Adverse event: Ocular hypertension (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 26 affected / 357 at risk

Adverse event: Vision blurred (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 18 affected / 357 at risk

Adverse event: Visual acuity reduced (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 21 affected / 357 at risk

Adverse event: Vitreous detachment (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 357 at risk

Adverse event: Vitreous floaters (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 19 affected / 357 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 357 at risk

Adverse event: Injection site pain (Study eye)
Serious: no
Organ System: General disorders
Frequency: 11 affected / 357 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 357 at risk

Adverse event: Conjunctivitis (Fellow untreated eye)
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 357 at risk

Adverse event: Conjunctivitis (Study eye)
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 357 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 357 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 357 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 39 affected / 357 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 357 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 357 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 357 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 357 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 357 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 15 affected / 357 at risk

Adverse event: Intraocular pressure increased (Fellow untreated eye)
Serious: no
Organ System: Investigations
Frequency: 11 affected / 357 at risk

Adverse event: Intraocular pressure increased (Study eye)
Serious: no
Organ System: Investigations
Frequency: 43 affected / 357 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 357 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 357 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 357 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 357 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 357 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 40 affected / 357 at risk