Study: NCT01304706

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 120 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 120 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 120 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 120 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 120 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 120 at risk

Adverse event: Ocular hypertension
Serious: yes
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 120 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 120 at risk

Adverse event: Vitreous haemorrhage
Serious: yes
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 120 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 120 at risk

Adverse event: Generalised oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 120 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Intraocular pressure increased
Serious: yes
Organ System: Investigations
Notes: #Study eye
Frequency: 3 affected / 120 at risk

Adverse event: Gout
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 120 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 120 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Acute leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 120 at risk

Adverse event: Rectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 120 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 120 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 120 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Nasal septum deviation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Cataract operation
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Study eye
Frequency: 5 affected / 120 at risk

Adverse event: Cataract operation
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Fellow eye
Frequency: 5 affected / 120 at risk

Adverse event: Colostomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 120 at risk

Adverse event: Glaucoma surgery
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Study eye
Frequency: 2 affected / 120 at risk

Adverse event: Glaucoma surgery
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Fellow eye
Frequency: 1 affected / 120 at risk

Adverse event: Surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 120 at risk

Adverse event: Trabeculectomy
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Fellow eye
Frequency: 1 affected / 120 at risk

Adverse event: Trabeculoplasty
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Study eye
Frequency: 1 affected / 120 at risk

Adverse event: Vitrectomy
Serious: yes
Organ System: Surgical and medical procedures
Notes: #Fellow eye
Frequency: 5 affected / 120 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 120 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 120 at risk

Adverse event: Anaemia of chronic disease
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Angina unstable
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 120 at risk

Adverse event: Aortic valve sclerosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 120 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 120 at risk

Adverse event: Arteriosclerosis coronary artery
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 120 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 120 at risk

Adverse event: Cardiomegaly
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 120 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 120 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 120 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 120 at risk

Adverse event: Arteriovenous malformation
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 120 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 120 at risk

Adverse event: Hyperparathyroidism secondary
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 120 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 120 at risk

Adverse event: Altered visual depth perception
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 120 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 3 affected / 120 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 3 affected / 120 at risk

Adverse event: Borderline glaucoma
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 120 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 12 affected / 120 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 9 affected / 120 at risk

Adverse event: Cataract cortical
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 120 at risk

Adverse event: Cataract nuclear
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 120 at risk

Adverse event: Cataract nuclear
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 120 at risk

Adverse event: Cataract subcapsular
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 3 affected / 120 at risk

Adverse event: Cataract subcapsular
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 2 affected / 120 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 28 affected / 120 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 2 affected / 120 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 2 affected / 120 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 120 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 120 at risk

Adverse event: Corneal striae
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 120 at risk

Adverse event: Corneal striae
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 120 at risk

Adverse event: Deposit eye
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 120 at risk

Adverse event: Diabetic retinal oedema
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 120 at risk

Adverse event: Diabetic retinopathy
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 120 at risk

Adverse event: Diabetic retinopathy
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 2 affected / 120 at risk

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 120 at risk

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 120 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 5 affected / 120 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 3 affected / 120 at risk

Adverse event: Erythema of eyelid
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 120 at risk

Adverse event: Erythema of eyelid
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 120 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 2 affected / 120 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 120 at risk

Adverse event: Eye haemorrhage
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 2 affected / 120 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 2 affected / 120 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 120 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 11 affected / 120 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 2 affected / 120 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 2 affected / 120 at risk

Adverse event: Eyelid cyst
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 120 at risk

Adverse event: Eyelid oedema
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 2 affected / 120 at risk

Adverse event: Eyelid ptosis
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 120 at risk

Adverse event: Eyelid ptosis
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 120 at risk

Adverse event: Eyelids pruritus
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 120 at risk

Adverse event: Foreign body sensation in eyes
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 120 at risk

Adverse event: Glaucoma
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 3 affected / 120 at risk

Adverse event: Glaucoma
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 120 at risk

Adverse event: Halo vision
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 120 at risk

Adverse event: Iris neovascularisation
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 120 at risk

Adverse event: Keratitis
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 120 at risk

Adverse event: Keratitis
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 120 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 120 at risk

Adverse event: Macular degeneration
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 120 at risk

Adverse event: Macular hole
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 120 at risk

Adverse event: Macular oedema
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 120 at risk

Adverse event: Maculopathy
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 5 affected / 120 at risk

Adverse event: Maculopathy
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 2 affected / 120 at risk

Adverse event: Metamorphopsia
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 120 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 6 affected / 120 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 2 affected / 120 at risk

Adverse event: Ocular discomfort
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 120 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 5 affected / 120 at risk

Adverse event: Ocular hypertension
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 7 affected / 120 at risk

Adverse event: Ocular hypertension
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 120 at risk

Adverse event: Open angle glaucoma
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 120 at risk

Adverse event: Papilloedema
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 120 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 4 affected / 120 at risk

Adverse event: Photophobia
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 120 at risk

Adverse event: Photopsia
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 2 affected / 120 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 120 at risk

Adverse event: Retinal depigmentation
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 120 at risk

Adverse event: Retinal detachment
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 120 at risk

Adverse event: Retinal exudates
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 2 affected / 120 at risk

Adverse event: Retinal exudates
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 3 affected / 120 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 120 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 3 affected / 120 at risk

Adverse event: Retinal pigment epitheliopathy
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 120 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 3 affected / 120 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 6 affected / 120 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 2 affected / 120 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 2 affected / 120 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 2 affected / 120 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 3 affected / 120 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 1 affected / 120 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 8 affected / 120 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Notes: #Fellow eye
Frequency: 5 affected / 120 at risk

Adverse event: Vitritis
Serious: no
Organ System: Eye disorders
Notes: #Study eye
Frequency: 1 affected / 120 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 120 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 120 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Diverticulum intestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Gastrointestinal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 120 at risk

Adverse event: Gingival disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Inguinal hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 120 at risk

Adverse event: Pneumoperitoneum
Serious: no
Organ System: Gastrointestinal disorders
Notes: #Fellow eye
Frequency: 1 affected / 120 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 120 at risk

Adverse event: Generalised oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 120 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 120 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 120 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 120 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 120 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Abdominal abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Abscess limb
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 120 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Gastritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 120 at risk

Adverse event: Genital infection fungal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Histoplasmosis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Infected cyst
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 120 at risk

Adverse event: Localised infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 120 at risk

Adverse event: Osteomyelitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 120 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 120 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 120 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 120 at risk

Adverse event: Avulsion fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 120 at risk

Adverse event: Corneal abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: #Study eye
Frequency: 1 affected / 120 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 120 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 120 at risk

Adverse event: Foot fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 120 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 120 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 120 at risk

Adverse event: Ligament rupture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 120 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 120 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 120 at risk

Adverse event: Toxicity to various agents
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 120 at risk

Adverse event: Tooth fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 120 at risk

Adverse event: Upper limb fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 120 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 120 at risk

Adverse event: Wrist fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 120 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 120 at risk

Adverse event: Blood magnesium decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 120 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 120 at risk

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 120 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Notes: #Study eye
Frequency: 13 affected / 120 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Notes: #Fellow eye
Frequency: 3 affected / 120 at risk

Adverse event: Intraocular pressure test abnormal
Serious: no
Organ System: Investigations
Notes: #Study eye
Frequency: 1 affected / 120 at risk

Adverse event: Platelet count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 120 at risk

Adverse event: Red blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 120 at risk

Adverse event: Very low density lipoprotein increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 120 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 120 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 120 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 120 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 120 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 120 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 120 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 120 at risk

Adverse event: Malnutrition
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 120 at risk

Adverse event: Obesity
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 120 at risk

Adverse event: Vitamin B12 deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 120 at risk

Adverse event: Vitamin D deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 120 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 120 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 120 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Exostosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Groin pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Head deformity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Intervertebral disc protrusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 120 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 120 at risk

Adverse event: Rhabdomyolysis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Spinal stenosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 120 at risk

Adverse event: Squamous cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 120 at risk

Adverse event: Carpal tunnel syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Complex regional pain syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Demyelination
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Diabetic neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 120 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 120 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 120 at risk

Adverse event: Neuritis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 120 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Transient ischaemic attack
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 120 at risk

Adverse event: VIth nerve paralysis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 120 at risk

Adverse event: Visual field defect
Serious: no
Organ System: Nervous system disorders
Notes: #Study eye
Frequency: 1 affected / 120 at risk

Adverse event: Visual field defect
Serious: no
Organ System: Nervous system disorders
Notes: #Fellow eye
Frequency: 1 affected / 120 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 120 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 120 at risk

Adverse event: Panic attack
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 120 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 120 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 120 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 120 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Choking
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 120 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 120 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Lung infiltration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Nasal septum deviation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Orthopnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 120 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 120 at risk

Adverse event: Cutis laxa
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: #Study eye
Frequency: 1 affected / 120 at risk

Adverse event: Cutis laxa
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: #Fellow eye
Frequency: 1 affected / 120 at risk

Adverse event: Dermal cyst
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Psoriasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 120 at risk

Adverse event: Aortic stenosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 120 at risk

Adverse event: Peripheral artery stenosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 120 at risk

Adverse event: Arteriosclerosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 120 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 120 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 120 at risk

Adverse event: Leriche syndrome
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 120 at risk