Study: NCT01217944

Adverse event: Myocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 106 at risk

Adverse event: Corneal erosion (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 106 at risk

Adverse event: Gastritis erosive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 106 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 106 at risk

Adverse event: Hepatic function abnormal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 106 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 106 at risk

Adverse event: Breast cancer in situ
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 106 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 106 at risk

Adverse event: Cataract (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 106 at risk

Adverse event: Conjunctival haemorrhage (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 106 at risk

Adverse event: Conjunctival hyperaemia (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 106 at risk

Adverse event: Conjunctivitis (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 106 at risk

Adverse event: Dry eye (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 106 at risk

Adverse event: Dry eye (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 106 at risk

Adverse event: Eye pain (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 106 at risk

Adverse event: Punctate keratitis (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 106 at risk

Adverse event: Vitreous detachment (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 106 at risk

Adverse event: Injection site haemorrhage (Study eye)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 106 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 106 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 106 at risk

Adverse event: Intraocular pressure increased (Study eye)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 106 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 106 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 106 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 106 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 118 at risk

Adverse event: Retinoschisis (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 118 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 118 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 118 at risk

Adverse event: Lung adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 118 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 118 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 118 at risk

Adverse event: Cataract (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 118 at risk

Adverse event: Conjunctival haemorrhage (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 118 at risk

Adverse event: Dry eye (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 118 at risk

Adverse event: Dry eye (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 118 at risk

Adverse event: Eye pain (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 118 at risk

Adverse event: Ocular hypertension (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 118 at risk

Adverse event: Punctate keratitis (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 118 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 118 at risk

Adverse event: Injection site haemorrhage (Study eye)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 118 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 118 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 118 at risk

Adverse event: Intraocular pressure increased (Study eye)
Serious: no
Organ System: Investigations
Frequency: 7 affected / 118 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 118 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 118 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 118 at risk

Adverse event: Blindness (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 38 at risk

Adverse event: Conjunctival haemorrhage (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 38 at risk

Adverse event: Eye pain (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 38 at risk

Adverse event: Ocular hypertension (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 38 at risk

Adverse event: Punctate keratitis (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 38 at risk

Adverse event: Visual impairment (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 38 at risk

Adverse event: Injection site haemorrhage (Study eye)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 38 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Intraocular pressure increased (Study eye)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 38 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 38 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 15 at risk

Adverse event: Blindness (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 15 at risk

Adverse event: Cataract (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 15 at risk

Adverse event: Conjunctival hyperaemia (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 15 at risk

Adverse event: Conjunctivitis (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 15 at risk

Adverse event: Dry eye (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 15 at risk

Adverse event: Dry eye (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 15 at risk

Adverse event: Eye pain (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 15 at risk

Adverse event: Ocular hypertension (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 15 at risk

Adverse event: Vitreous detachment (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 15 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Conjunctivitis viral (Study eye)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Localised infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 15 at risk

Adverse event: Tinea pedis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Myositis (Study eye)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk