Study: NCT01396057

Adverse event: Atrioventricular block second degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 126 at risk

Adverse event: Bradyarrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 126 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Large intestine polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Type 2 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 126 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Rheumatic disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 126 at risk

Adverse event: Renal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 126 at risk

Adverse event: Diabetic nephropathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 126 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 126 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: ABNORMAL SENSATION IN EYE (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 126 at risk

Adverse event: BLEPHARITIS (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 126 at risk

Adverse event: BLEPHARITIS (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 126 at risk

Adverse event: CATARACT (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 126 at risk

Adverse event: CONJUNCTIVAL HAEMORRHAGE (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 126 at risk

Adverse event: CONJUNCTIVAL IRRITATION (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 126 at risk

Adverse event: CONJUNCTIVITIS (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 126 at risk

Adverse event: EYE DISCHARGE (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 126 at risk

Adverse event: EYE IRRITATION (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 126 at risk

Adverse event: EYE IRRITATION (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 126 at risk

Adverse event: EYE PAIN (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 126 at risk

Adverse event: FOREIGN BODY SENSATION IN EYES (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 126 at risk

Adverse event: GLAUCOMA (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 126 at risk

Adverse event: LACRIMATION INCREASED (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 126 at risk

Adverse event: LACRIMATION INCREASED (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 126 at risk

Adverse event: MACULAR OEDEMA (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 126 at risk

Adverse event: OCULAR DISCOMFORT (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 126 at risk

Adverse event: OCULAR HYPERAEMIA (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 16 affected / 126 at risk

Adverse event: RETINAL EXUDATES (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 126 at risk

Adverse event: VISION BLURRED (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 126 at risk

Adverse event: VISUAL ACUITY REDUCED (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 126 at risk

Adverse event: VITREOUS DETACHMENT (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 126 at risk

Adverse event: VITREOUS FLOATERS (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 126 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 126 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 126 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 126 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 126 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 126 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 126 at risk

Adverse event: INTRAOCULAR PRESSURE INCREASED (Study eye)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 126 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 126 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 126 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 126 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 126 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 126 at risk

Adverse event: VASCULAR SHUNT (Study eye)
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 126 at risk

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

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

Adverse event: Abdominal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 118 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 118 at risk

Adverse event: CELLULITIS (Study eye)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 118 at risk

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

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

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

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

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

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

Adverse event: Urethral prolapse
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 118 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 118 at risk

Adverse event: Circulatory collapse
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 118 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 118 at risk

Adverse event: ABNORMAL SENSATION IN EYE (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 118 at risk

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

Adverse event: BLEPHARITIS (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 118 at risk

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

Adverse event: CONJUNCTIVAL HAEMORRHAGE (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 118 at risk

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

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

Adverse event: EYE DISCHARGE (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 118 at risk

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

Adverse event: EYE IRRITATION (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 118 at risk

Adverse event: EYE PAIN (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 118 at risk

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

Adverse event: FOREIGN BODY SENSATION IN EYES (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 118 at risk

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

Adverse event: LACRIMATION INCREASED (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 118 at risk

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

Adverse event: MACULAR OEDEMA (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 118 at risk

Adverse event: OCULAR DISCOMFORT (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 118 at risk

Adverse event: OCULAR HYPERAEMIA (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 21 affected / 118 at risk

Adverse event: OCULAR HYPERTENSION (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 118 at risk

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

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

Adverse event: VISUAL ACUITY REDUCED (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 118 at risk

Adverse event: VITREOUS DETACHMENT (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 118 at risk

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

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal 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: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 118 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 118 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 118 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 118 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 19 affected / 118 at risk

Adverse event: INTRAOCULAR PRESSURE INCREASED (Study eye)
Serious: no
Organ System: Investigations
Frequency: 17 affected / 118 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 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: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 118 at risk

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