Study: NCT01922102

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 182 at risk

Adverse event: Retinal detachment (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 182 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 182 at risk

Adverse event: Varices oesophageal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 182 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 182 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 182 at risk

Adverse event: Gastrointestinal stromal tumour
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 182 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 182 at risk

Adverse event: Henoch-Schonlein purpura
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 182 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 182 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 182 at risk

Adverse event: Cataract (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 182 at risk

Adverse event: Choroidal neovascularisation (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 182 at risk

Adverse event: Choroidal neovascularisation (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 182 at risk

Adverse event: Conjunctival deposit (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 182 at risk

Adverse event: Conjunctival deposit (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 182 at risk

Adverse event: Conjunctival haemorrhage (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 182 at risk

Adverse event: Conjunctival hyperaemia (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 182 at risk

Adverse event: Conjunctivitis allergic (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 182 at risk

Adverse event: Dry eye (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 182 at risk

Adverse event: Dry eye (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 182 at risk

Adverse event: Exophthalmos (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 182 at risk

Adverse event: Exophthalmos (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 182 at risk

Adverse event: Eye pain (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 182 at risk

Adverse event: Eye pain (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 182 at risk

Adverse event: Eye pruritus (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 182 at risk

Adverse event: Eye swelling (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 182 at risk

Adverse event: Macular fibrosis (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 182 at risk

Adverse event: Macular hole (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 182 at risk

Adverse event: Metamorphopsia (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 182 at risk

Adverse event: Ocular discomfort (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 182 at risk

Adverse event: Ocular discomfort (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 182 at risk

Adverse event: Ocular hypertension (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 182 at risk

Adverse event: Pathologic myopia (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 182 at risk

Adverse event: Posterior capsule opacification (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 182 at risk

Adverse event: Retinal haemorrhage (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 182 at risk

Adverse event: Retinal haemorrhage (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 182 at risk

Adverse event: Visual acuity reduced (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 182 at risk

Adverse event: Visual acuity reduced (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 182 at risk

Adverse event: Visual impairment (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 182 at risk

Adverse event: Vitreous opacities (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 182 at risk

Adverse event: Xerophthalmia (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 182 at risk

Adverse event: Xerophthalmia (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 182 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 182 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 182 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 182 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 182 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 182 at risk

Adverse event: Loose tooth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 182 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 182 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 2 affected / 182 at risk

Adverse event: Peripheral swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 182 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 182 at risk

Adverse event: Cholecystitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 182 at risk

Adverse event: Cholecystitis chronic
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 182 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 182 at risk

Adverse event: Conjunctivitis (Fellow eye)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 182 at risk

Adverse event: Conjunctivitis (Study eye)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 182 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 182 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 182 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 182 at risk

Adverse event: Hordeolum (Study eye)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 182 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 182 at risk

Adverse event: Periodontitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 182 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 182 at risk

Adverse event: Pulpitis dental
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 182 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 182 at risk

Adverse event: Urethritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 182 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 182 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 182 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 182 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 182 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 182 at risk

Adverse event: Bacterial test positive
Serious: no
Organ System: Investigations
Frequency: 2 affected / 182 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 182 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 182 at risk

Adverse event: Blood uric acid increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 182 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 182 at risk

Adverse event: Intraocular pressure increased (Fellow eye)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 182 at risk

Adverse event: Intraocular pressure increased (Study eye)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 182 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 182 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 3 affected / 182 at risk

Adverse event: Red blood cells urine positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 182 at risk

Adverse event: White blood cells urine positive
Serious: no
Organ System: Investigations
Frequency: 2 affected / 182 at risk

Adverse event: Visual acuity tests abnormal (Study eye)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 182 at risk

Adverse event: White blood cells urine positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 182 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 182 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 182 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 182 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 182 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 182 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 182 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 182 at risk

Adverse event: Menopausal symptoms
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 182 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 182 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 182 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 182 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 182 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 182 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 182 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 185 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 185 at risk

Adverse event: Retinal detachment (Fellow eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 185 at risk

Adverse event: Retinal detachment (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 185 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 185 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 185 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 185 at risk

Adverse event: Hepatic steatosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 185 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Pharyngitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Radius fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 185 at risk

Adverse event: Osteoporotic fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 185 at risk

Adverse event: Bladder neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 185 at risk

Adverse event: Bladder hyperaemia
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 185 at risk

Adverse event: Cataract (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 185 at risk

Adverse event: Choroidal neovascularisation (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 185 at risk

Adverse event: Choroidal neovascularisation (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 185 at risk

Adverse event: Conjunctival deposit (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 185 at risk

Adverse event: Conjunctival deposit (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 185 at risk

Adverse event: Conjunctival haemorrhage (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 185 at risk

Adverse event: Conjunctival hyperaemia (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 185 at risk

Adverse event: Conjunctivitis allergic (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 185 at risk

Adverse event: Conjunctivitis allergic (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 185 at risk

Adverse event: Dry eye (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 185 at risk

Adverse event: Dry eye (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 185 at risk

Adverse event: Eye pain (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 185 at risk

Adverse event: Eye pain (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 185 at risk

Adverse event: Eye pruritus (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 185 at risk

Adverse event: Eye swelling (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 185 at risk

Adverse event: Eye swelling (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 185 at risk

Adverse event: Macular fibrosis (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 185 at risk

Adverse event: Metamorphopsia (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 185 at risk

Adverse event: Metamorphopsia (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 185 at risk

Adverse event: Ocular discomfort (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 185 at risk

Adverse event: Ocular discomfort (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 185 at risk

Adverse event: Ocular hypertension (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 185 at risk

Adverse event: Photopsia (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 185 at risk

Adverse event: Posterior capsule opacification (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 185 at risk

Adverse event: Retinal haemorrhage (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 185 at risk

Adverse event: Retinal haemorrhage (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 185 at risk

Adverse event: Vision blurred (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 185 at risk

Adverse event: Visual acuity reduced (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 185 at risk

Adverse event: Vitreous opacities (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 185 at risk

Adverse event: Vitreous opacities (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 185 at risk

Adverse event: Xerophthalmia (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 185 at risk

Adverse event: Xerophthalmia (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 185 at risk

Adverse event: Chronic gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 185 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 185 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 185 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 185 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 185 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 185 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 185 at risk

Adverse event: Hepatic steatosis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 185 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 185 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Conjunctivitis (Fellow eye)
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 185 at risk

Adverse event: Conjunctivitis (Study eye)
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 185 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 185 at risk

Adverse event: Periodontitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 185 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 185 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 185 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 185 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 185 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 185 at risk

Adverse event: Bacterial test positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 185 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 185 at risk

Adverse event: Blood uric acid increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 185 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 185 at risk

Adverse event: Intraocular pressure increased (Fellow eye)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 185 at risk

Adverse event: Intraocular pressure increased (Study eye)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 185 at risk

Adverse event: Pregnancy test positive
Serious: no
Organ System: Investigations
Frequency: 2 affected / 185 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 3 affected / 185 at risk

Adverse event: Visual acuity tests abnormal (Study eye)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 185 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 185 at risk

Adverse event: White blood cells urine positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 185 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 185 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 185 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 185 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 185 at risk

Adverse event: Intervertebral disc protrusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 185 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 185 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 185 at risk

Adverse event: Spinal osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 185 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 185 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 185 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 185 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 185 at risk

Adverse event: Breast hyperplasia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 185 at risk

Adverse event: Menstruation irregular
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 185 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 185 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 185 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 185 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 185 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 75 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 75 at risk

Adverse event: Retinal detachment (Fellow eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 75 at risk

Adverse event: Anorectal polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Endophthalmitis (Study eye)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Physical examination abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 75 at risk

Adverse event: Shock hypoglycaemic
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 75 at risk

Adverse event: Type 2 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 75 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 75 at risk

Adverse event: Oligoastrocytoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 75 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Ventricular extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 75 at risk

Adverse event: Deafness neurosensory
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 75 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 75 at risk

Adverse event: Choroidal neovascularisation (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 75 at risk

Adverse event: Conjunctival haemorrhage (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 75 at risk

Adverse event: Conjunctivitis allergic (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 75 at risk

Adverse event: Conjunctivitis allergic (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 75 at risk

Adverse event: Diplopia (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 75 at risk

Adverse event: Dry eye (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 75 at risk

Adverse event: Exophthalmos (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 75 at risk

Adverse event: Eye pain (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 75 at risk

Adverse event: Eye swelling (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 75 at risk

Adverse event: Foreign body sensation in eyes (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 75 at risk

Adverse event: Macular fibrosis (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 75 at risk

Adverse event: Ocular discomfort (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 75 at risk

Adverse event: Ocular discomfort (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 75 at risk

Adverse event: Ocular hypertension (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 75 at risk

Adverse event: Pathologic myopia (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 75 at risk

Adverse event: Photopsia (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 75 at risk

Adverse event: Retinal haemorrhage (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 75 at risk

Adverse event: Visual acuity reduced (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 75 at risk

Adverse event: Vitreous floaters (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 75 at risk

Adverse event: Xerophthalmia (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 75 at risk

Adverse event: Xerophthalmia (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 75 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Chronic gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Gastritis erosive
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 75 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Glossitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Hiatus hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Loose tooth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 75 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Cholecystitis chronic
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 75 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 75 at risk

Adverse event: Hepatic steatosis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 75 at risk

Adverse event: Allergy to chemicals
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Conjunctivitis (Fellow eye)
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 75 at risk

Adverse event: Conjunctivitis (Study eye)
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 75 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Gastroenteritis shigella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Hordeolum (Study eye)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 75 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 75 at risk

Adverse event: Urethritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 75 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 75 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 75 at risk

Adverse event: Spinal column injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 75 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 75 at risk

Adverse event: Bacterial test positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 75 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 75 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 75 at risk

Adverse event: Blood uric acid increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 75 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Investigations
Frequency: 2 affected / 75 at risk

Adverse event: Intraocular pressure increased (Fellow eye)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 75 at risk

Adverse event: Intraocular pressure increased (Study eye)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 75 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 75 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 2 affected / 75 at risk

Adverse event: Red blood cells urine positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 75 at risk

Adverse event: Urine ketone body present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 75 at risk

Adverse event: Visual acuity tests abnormal (Study eye)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 75 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 75 at risk

Adverse event: White blood cells urine positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 75 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 75 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 75 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 75 at risk

Adverse event: Intervertebral disc protrusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 75 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 75 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 75 at risk

Adverse event: Sjogren's syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 75 at risk

Adverse event: Tenosynovitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 75 at risk

Adverse event: Benign neoplasm of thyroid gland
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 75 at risk

Adverse event: Seborrhoeic keratosis
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 75 at risk

Adverse event: Diabetic neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 75 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 75 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 75 at risk

Adverse event: Breast hyperplasia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 75 at risk

Adverse event: Breast swelling
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 75 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 75 at risk

Adverse event: Menopausal symptoms
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 75 at risk

Adverse event: Menstruation irregular
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 75 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 75 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 75 at risk

Adverse event: Rhinalgia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 75 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 75 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 75 at risk

Adverse event: Arteriosclerosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 75 at risk

Adverse event: Diabetic vascular disorder
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 75 at risk

Adverse event: Hyperaemia (Study eye)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 75 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 75 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 14 at risk

Adverse event: Choroidal neovascularisation (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Conjunctivitis allergic (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Conjunctivitis allergic (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Dry eye (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Dry eye (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Eye pain (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Eye pruritus (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Eye swelling (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Eye swelling (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Metamorphopsia (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Metamorphopsia (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Retinal haemorrhage (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 14 at risk

Adverse event: Retinal haemorrhage (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Conjunctivitis (Fellow eye)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Conjunctivitis (Study eye)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Joint dislocation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 14 at risk

Adverse event: Rheumatic disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Trigeminal neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 14 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 14 at risk