Study: NCT01908816

Adverse event: Macular fibrosis (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Ocular hypertension (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Retinal pigment epithelial tear (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Visual acuity reduced (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Pancreatic mass
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 93 at risk

Adverse event: Corneal abscess (Study eye)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Peritonsillar abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Syphilis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 93 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 93 at risk

Adverse event: Alcohol withdrawal syndrome
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 93 at risk

Adverse event: Hallucination
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 93 at risk

Adverse event: Nephroangiosclerosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 93 at risk

Adverse event: Eye pain (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 93 at risk

Adverse event: Eye pruritus (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 93 at risk

Adverse event: Ocular hyperaemia (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Punctate keratitis (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Vision blurred (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 93 at risk

Adverse event: Visual acuity reduced (Contralateral eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 93 at risk

Adverse event: Visual acuity reduced (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 93 at risk

Adverse event: Drug ineffective (Study eye)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 93 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 93 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Conjunctivitis (Both eyes)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Conjunctivitis (Study eye)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 93 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 93 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 93 at risk

Adverse event: Inappropriate schedule of drug administration (Study eye)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 93 at risk

Adverse event: Incorrect product storage (Study eye)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 93 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 93 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 93 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 93 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 93 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 93 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 93 at risk

Adverse event: Myocardial ischaemia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 93 at risk

Adverse event: Blepharitis (Both eyes)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Blepharitis (Contralateral eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Blepharospasm (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Cataract (Both eyes)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Cataract subcapsular (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Choroidal neovascularisation (Contralateral eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Choroiditis (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Conjunctival hyperaemia (Both eyes)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Conjunctival hyperaemia (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Conjunctivitis allergic (Both eyes)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Dry eye (Both eyes)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Eye inflammation (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Eye irritation (Both eyes)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 93 at risk

Adverse event: Eye irritation (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Eye pruritus (Both eyes)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Eye ulcer (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Eyelid cyst (Contralateral eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Eyelid irritation (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Eyelid myoclonus (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Foreign body sensation in eyes (Contralateral eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Glare (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Macular fibrosis (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 93 at risk

Adverse event: Macular oedema (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Metamorphopsia (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 93 at risk

Adverse event: Ocular hypertension (Contralateral eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Photophobia (Both eyes)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Photopsia (Both eyes)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Photopsia (Contralateral eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Photopsia (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Retinal detachment (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Retinal neovascularisation (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Retinal oedema (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Retinal pigment epithelial tear (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Retinal pigment epitheliopathy (Both eyes)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Uveitis (Both eyes)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Visual impairment (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Vitreous floaters (Both eyes)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Vitreous floaters (Contralateral eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Vitreous floaters (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 93 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Pulpless tooth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Pancreatitis acute
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 93 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 93 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 93 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Maternal exposure during pregnancy
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 93 at risk

Adverse event: Rib fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 93 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 93 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 93 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 93 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 93 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 93 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 93 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 93 at risk

Adverse event: Carotid artery stenosis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 93 at risk

Adverse event: Migraine with aura
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 93 at risk

Adverse event: Visual field defect (Study eye)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 93 at risk

Adverse event: Amenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 93 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Sinus polyp
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 93 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 93 at risk

Adverse event: Cataract (Contralateral eye)
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 84 at risk

Adverse event: Cataract (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Ocular hypertension (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Vitreous adhesions (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Vitreous haemorrhage (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 84 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Gastrointestinal dysplasia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Influenza
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: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 84 at risk

Adverse event: Tendon rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 84 at risk

Adverse event: Intraocular pressure increased (Study eye)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 84 at risk

Adverse event: Metastases to liver
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 84 at risk

Adverse event: Akinesia
Serious: yes
Organ System: Nervous system 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: Completed suicide
Serious: yes
Organ System: Psychiatric 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: Atelectasis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Cataract (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 84 at risk

Adverse event: Conjunctival haemorrhage (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 84 at risk

Adverse event: Dry eye (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 84 at risk

Adverse event: Eye pain (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 84 at risk

Adverse event: Eye pruritus (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Ulcerative keratitis (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Vision blurred (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Visual acuity reduced (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 84 at risk

Adverse event: Drug ineffective (Study eye)
Serious: no
Organ System: General disorders
Frequency: 27 affected / 84 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 84 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 84 at risk

Adverse event: Conjunctivitis (Both eyes)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Sinusitis
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: 2 affected / 84 at risk

Adverse event: Viral upper respiratory 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: Inappropriate schedule of drug administration (Study eye)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 21 affected / 84 at risk

Adverse event: Incorrect product storage (Study eye)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 84 at risk

Adverse event: Blood urea increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 84 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 84 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 84 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 84 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 84 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 84 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 84 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 84 at risk

Adverse event: Ear discomfort
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 84 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 84 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 84 at risk

Adverse event: Thyroid mass
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 84 at risk

Adverse event: Conjunctival haemorrhage (Contralateral eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Conjunctival hyperaemia (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Conjunctivitis allergic (Both eyes)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Cystoid macular oedema (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Dry eye (Both eyes)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Eczema eyelids (Contralateral eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Exophthalmos (Both eyes)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Eye allergy (Both eyes)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Foreign body sensation in eyes (Both eyes)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Glare (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Keratitis (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Macular oedema (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Ocular hypertension (Both eyes)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Photophobia (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Retinal detachment (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Visual acuity reduced (Both eyes)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Vitreous floaters (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Vitritis (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 84 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Noninfective gingivitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Facial pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 84 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 1 affected / 84 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 84 at risk

Adverse event: Injection site ulcer (Study eye)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 84 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 84 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 84 at risk

Adverse event: Eye infection (Study eye)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Tracheitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Bone fissure
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 84 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 84 at risk

Adverse event: Rib fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 84 at risk

Adverse event: Wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 84 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 84 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 84 at risk

Adverse event: Eosinophil count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 84 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 84 at risk

Adverse event: Intraocular pressure increased (Contralateral eye)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 84 at risk

Adverse event: Intraocular pressure increased (Study eye)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 84 at risk

Adverse event: Neutrophil count increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 84 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 84 at risk

Adverse event: Ankylosing spondylitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: Polyarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: Tendon pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: Cutaneous lymphoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 84 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 84 at risk

Adverse event: Transient ischaemic attack
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 84 at risk

Adverse event: Affective disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 84 at risk

Adverse event: Prostatitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 84 at risk

Adverse event: Lung disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 84 at risk

Adverse event: Peripheral vascular disorder
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 84 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 58 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 58 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 58 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 58 at risk

Adverse event: Ischaemic cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 58 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 58 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 58 at risk

Adverse event: Anterior chamber fibrin (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 58 at risk

Adverse event: Cataract (Contralateral eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 58 at risk

Adverse event: Glaucoma (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 58 at risk

Adverse event: Ocular hypertension (Both eyes)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 58 at risk

Adverse event: Ocular hypertension (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 7 affected / 58 at risk

Adverse event: Retinal detachment (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 58 at risk

Adverse event: Visual acuity reduced (Both eyes)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 58 at risk

Adverse event: Visual acuity reduced (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 58 at risk

Adverse event: Vitreous haemorrhage (Contralateral eye)
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 58 at risk

Adverse event: Vitreous haemorrhage (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 58 at risk

Adverse event: Duodenal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Drug ineffective (Study eye)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 58 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 58 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 58 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 58 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 58 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 58 at risk

Adverse event: Muscle rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 58 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 58 at risk

Adverse event: Intraocular pressure increased (Study eye)
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 58 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 58 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 58 at risk

Adverse event: Adenocarcinoma pancreas
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 58 at risk

Adverse event: Choroid melanoma (Study eye)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 58 at risk

Adverse event: Chronic myeloid leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 58 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 58 at risk

Adverse event: Hypoglycaemic coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 58 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 58 at risk

Adverse event: Vertebrobasilar insufficiency
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 58 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 58 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 58 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 58 at risk

Adverse event: Arterial disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 58 at risk

Adverse event: Cataract (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 58 at risk

Adverse event: Dry eye (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 58 at risk

Adverse event: Eye pain (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 58 at risk

Adverse event: Eye pruritus (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 58 at risk

Adverse event: Ocular hyperaemia (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 58 at risk

Adverse event: Ocular hypertension (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 58 at risk

Adverse event: Punctate keratitis (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 58 at risk

Adverse event: Ulcerative keratitis (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 58 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 58 at risk

Adverse event: Drug ineffective (Study eye)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 58 at risk

Adverse event: Conjunctivitis (Study eye)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 58 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 58 at risk

Adverse event: Inappropriate schedule of drug administration (Study eye)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 58 at risk

Adverse event: Incorrect product storage (Study eye)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 58 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 58 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 58 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 58 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 58 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 58 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 58 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 58 at risk

Adverse event: Anterior chamber fibrin (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 58 at risk

Adverse event: Blepharitis (Both eyes)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 58 at risk

Adverse event: Blepharitis (Contralateral eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 58 at risk

Adverse event: Cataract (Contralateral eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 58 at risk

Adverse event: Chalazion (Contralateral eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 58 at risk

Adverse event: Corneal perforation (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 58 at risk

Adverse event: Eye discharge (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 58 at risk

Adverse event: Eye haemorrhage (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 58 at risk

Adverse event: Eye pain (Both eyes)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 58 at risk

Adverse event: Eye pain (Contralateral eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 58 at risk

Adverse event: Eyelid pain (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 58 at risk

Adverse event: Eyelid ptosis (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 58 at risk

Adverse event: Foreign body sensation in eyes (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 58 at risk

Adverse event: Glaucoma (Both eyes)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 58 at risk

Adverse event: Iridocyclitis (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 58 at risk

Adverse event: Iris neovascularisation (Contralateral eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 58 at risk

Adverse event: Ocular discomfort (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 58 at risk

Adverse event: Ocular hypertension (Both eyes)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 58 at risk

Adverse event: Punctate keratitis (Contralateral eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 58 at risk

Adverse event: Retinal haemorrhage (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 58 at risk

Adverse event: Vision blurred (Both eyes)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 58 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Secretion discharge (Study eye)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Liver disorder
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 58 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 58 at risk

Adverse event: Conjunctival laceration (Study eye)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 58 at risk

Adverse event: Hyphaema (Study eye)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 58 at risk

Adverse event: Incorrect product storage (Contralateral eye)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 58 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 58 at risk

Adverse event: Intraocular pressure increased (Study eye)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 58 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 58 at risk

Adverse event: Folate deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 58 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 58 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 58 at risk

Adverse event: Osteitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 58 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 58 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 58 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 58 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 58 at risk

Adverse event: Decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 58 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 35 at risk

Adverse event: Blindness (Both eyes)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk

Adverse event: Cataract (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk

Adverse event: Glaucoma (Contralateral eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk

Adverse event: Glaucoma (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk

Adverse event: Macular detachment (Both eyes)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk

Adverse event: Retinal artery occlusion (Both eyes)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk

Adverse event: Retinal detachment (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk

Adverse event: Retinal tear (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk

Adverse event: Visual acuity reduced (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk

Adverse event: Vitreous adhesions (Contralateral eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk

Adverse event: Vitreous haemorrhage (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk

Adverse event: Gastrointestinal angiodysplasia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 35 at risk

Adverse event: Post procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 35 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 35 at risk

Adverse event: Osteoarthropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 35 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 35 at risk

Adverse event: Lung disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Extremity necrosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 35 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 35 at risk

Adverse event: Peripheral artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 35 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 35 at risk

Adverse event: Shock haemorrhagic
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 35 at risk

Adverse event: Conjunctival haemorrhage (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk

Adverse event: Eye pain (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 35 at risk

Adverse event: Ocular hyperaemia (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk

Adverse event: Ocular hypertension (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 35 at risk

Adverse event: Punctate keratitis (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk

Adverse event: Ulcerative keratitis (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 35 at risk

Adverse event: Vision blurred (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 35 at risk

Adverse event: Visual acuity reduced (Contralateral eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk

Adverse event: Visual acuity reduced (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Conjunctivitis (Both eyes)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Conjunctivitis (Study eye)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Inappropriate schedule of drug administration (Study eye)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 35 at risk

Adverse event: Blood urea increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 35 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Thrombocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Allergic keratitis (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk

Adverse event: Conjunctival ulcer (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk

Adverse event: Eye inflammation (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk

Adverse event: Eye oedema (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk

Adverse event: Eye pain (Both eyes)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk

Adverse event: Eye pruritus (Both eyes)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk

Adverse event: Foreign body sensation in eyes (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk

Adverse event: Keratitis (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk

Adverse event: Lacrimation increased (Both eyes)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk

Adverse event: Ocular discomfort (Contralateral eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk

Adverse event: Photophobia (Contralateral eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk

Adverse event: Photopsia (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk

Adverse event: Visual acuity reduced (Both eyes)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk

Adverse event: Vitreous haemorrhage (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 35 at risk

Adverse event: Inflammation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Genital infection female
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Infected bite
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Post procedural infection (Study eye)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 35 at risk

Adverse event: Red blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 35 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 35 at risk

Adverse event: Diabetic nephropathy
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 35 at risk

Adverse event: Microalbuminuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 35 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 35 at risk