Study: NCT01580020

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: CONJUNCTIVAL HAEMORRHAGE (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 52 at risk

Adverse event: CONJUNCTIVAL IRRITATION (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 52 at risk

Adverse event: DRY EYE (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 52 at risk

Adverse event: DRY EYE (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 52 at risk

Adverse event: EYE PAIN (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 52 at risk

Adverse event: LACRIMATION INCREASED (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 52 at risk

Adverse event: MACULAR OEDEMA (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 52 at risk

Adverse event: OCULAR DISCOMFORT (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 52 at risk

Adverse event: OCULAR HYPERAEMIA (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 52 at risk

Adverse event: RETINAL EXUDATES (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 52 at risk

Adverse event: RETINAL ISCHAEMIA (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 52 at risk

Adverse event: RETINAL OEDEMA (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 52 at risk

Adverse event: VISION BLURRED (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 52 at risk

Adverse event: VISUAL ACUITY REDUCED (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 52 at risk

Adverse event: VITREOUS DETACHMENT (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 52 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 52 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 52 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 52 at risk

Adverse event: Periodontitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 52 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 52 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 52 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 52 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 52 at risk

Adverse event: INTRAOCULAR PRESSURE INCREASED (Study eye)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 52 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 52 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 52 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 52 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 52 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 52 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Rotator cuff syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Lumbar radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Psoriasis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: CATARACT (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 40 at risk

Adverse event: CONJUNCTIVAL HAEMORRHAGE (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 40 at risk

Adverse event: CONJUNCTIVAL IRRITATION (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 40 at risk

Adverse event: CONJUNCTIVITIS ALLERGIC (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 40 at risk

Adverse event: DRY EYE (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 40 at risk

Adverse event: DRY EYE (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 40 at risk

Adverse event: FOREIGN BODY SENSATION IN EYES (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 40 at risk

Adverse event: GLAUCOMA (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 40 at risk

Adverse event: LACRIMATION INCREASED (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 40 at risk

Adverse event: MACULAR OEDEMA (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 40 at risk

Adverse event: OCULAR DISCOMFORT (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 40 at risk

Adverse event: OCULAR HYPERAEMIA (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 40 at risk

Adverse event: RETINAL EXUDATES (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 40 at risk

Adverse event: RETINAL ISCHAEMIA (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 40 at risk

Adverse event: RETINAL OEDEMA (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 40 at risk

Adverse event: VISUAL ACUITY REDUCED (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 40 at risk

Adverse event: VITREOUS DETACHMENT (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 40 at risk

Adverse event: VITREOUS DETACHMENT (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 40 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 40 at risk

Adverse event: CONJUNCTIVITIS (Study eye)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 40 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 40 at risk

Adverse event: INTRAOCULAR PRESSURE INCREASED (Study eye)
Serious: no
Organ System: Investigations
Frequency: 10 affected / 40 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 40 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 40 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: GLAUCOMA (Fellow eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 61 at risk

Adverse event: GLAUCOMA (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 61 at risk

Adverse event: IRIS NEOVASCULARISATION (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 61 at risk

Adverse event: MACULAR OEDEMA (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 61 at risk

Adverse event: OCULAR ISCHAEMIC SYNDROME (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 61 at risk

Adverse event: VISUAL ACUITY REDUCED (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 61 at risk

Adverse event: VITREOUS HAEMORRHAGE (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 61 at risk

Adverse event: Squamous cell carcinoma of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 61 at risk

Adverse event: Substance abuse
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 61 at risk

Adverse event: CATARACT (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 61 at risk

Adverse event: CONJUNCTIVAL HAEMORRHAGE (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 61 at risk

Adverse event: CONJUNCTIVAL HYPERAEMIA (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 61 at risk

Adverse event: EYE PAIN (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 61 at risk

Adverse event: FOREIGN BODY SENSATION IN EYES (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 61 at risk

Adverse event: GLAUCOMA (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 61 at risk

Adverse event: LACRIMATION INCREASED (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 61 at risk

Adverse event: MACULAR FIBROSIS (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 61 at risk

Adverse event: MACULAR OEDEMA (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 61 at risk

Adverse event: OCULAR DISCOMFORT (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 61 at risk

Adverse event: OCULAR HYPERAEMIA (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 61 at risk

Adverse event: PHOTOPSIA (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 61 at risk

Adverse event: RETINAL ISCHAEMIA (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 61 at risk

Adverse event: VISION BLURRED (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 61 at risk

Adverse event: VISUAL ACUITY REDUCED (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 61 at risk

Adverse event: VISUAL IMPAIRMENT (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 61 at risk

Adverse event: VITREOUS DETACHMENT (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 61 at risk

Adverse event: VITREOUS DETACHMENT (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 61 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 61 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 61 at risk

Adverse event: CONJUNCTIVITIS (Study eye)
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 61 at risk

Adverse event: Gastrointestinal infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 61 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 61 at risk

Adverse event: Periodontitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: INTRAOCULAR PRESSURE INCREASED (Study eye)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 61 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 61 at risk

Adverse event: Sjogren's syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 61 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 61 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 61 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 61 at risk

Adverse event: RETINAL DETACHMENT (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk

Adverse event: VITREOUS HAEMORRHAGE (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk

Adverse event: Factor V Leiden mutation
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 22 at risk

Adverse event: CATARACT (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk

Adverse event: CONJUNCTIVAL HAEMORRHAGE (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 22 at risk

Adverse event: CONJUNCTIVAL HYPERAEMIA (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk

Adverse event: CONJUNCTIVITIS ALLERGIC (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk

Adverse event: EYE PAIN (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 22 at risk

Adverse event: GLAUCOMA (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk

Adverse event: LACRIMATION INCREASED (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 22 at risk

Adverse event: MACULAR OEDEMA (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 22 at risk

Adverse event: OCULAR HYPERAEMIA (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 22 at risk

Adverse event: VISION BLURRED (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk

Adverse event: VISUAL ACUITY REDUCED (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk

Adverse event: VISUAL IMPAIRMENT (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 22 at risk

Adverse event: Periodontitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 22 at risk

Adverse event: POST PROCEDURAL SWELLING (Study eye)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 22 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 22 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 22 at risk

Adverse event: INTRAOCULAR PRESSURE DECREASED (Study eye)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 22 at risk

Adverse event: INTRAOCULAR PRESSURE INCREASED (Study eye)
Serious: no
Organ System: Investigations
Frequency: 4 affected / 22 at risk

Adverse event: Vitamin D deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 22 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Trigeminal neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 22 at risk