Study: NCT01396083

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 124 at risk

Adverse event: Adenomatous polyposis coli
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 124 at risk

Adverse event: MACULAR OEDEMA (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 124 at risk

Adverse event: RETINAL VEIN OCCLUSION (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 124 at risk

Adverse event: Gastroduodenal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Oesophageal rupture
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 124 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 124 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 124 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 124 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 124 at risk

Adverse event: Prostatic specific antigen increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 124 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 124 at risk

Adverse event: Prostatitis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 124 at risk

Adverse event: ABNORMAL SENSATION IN EYE (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 124 at risk

Adverse event: CONJUNCTIVAL HAEMORRHAGE (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 16 affected / 124 at risk

Adverse event: DRY EYE (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 124 at risk

Adverse event: DRY EYE (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 124 at risk

Adverse event: EYE IRRITATION (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 124 at risk

Adverse event: EYE PAIN (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 15 affected / 124 at risk

Adverse event: FOREIGN BODY SENSATION IN EYES (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 124 at risk

Adverse event: LACRIMATION INCREASED (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 124 at risk

Adverse event: MACULAR OEDEMA (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 124 at risk

Adverse event: OCULAR HYPERAEMIA (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 124 at risk

Adverse event: OPTIC DISC VASCULAR DISORDER (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 124 at risk

Adverse event: RETINAL EXUDATES (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 124 at risk

Adverse event: RETINAL ISCHAEMIA (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 124 at risk

Adverse event: RETINAL VASCULAR DISORDER (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 124 at risk

Adverse event: VISUAL ACUITY REDUCED (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 124 at risk

Adverse event: VISUAL IMPAIRMENT (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 124 at risk

Adverse event: VITREOUS DETACHMENT (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 124 at risk

Adverse event: VITREOUS FLOATERS (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 124 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 124 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 124 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 124 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 124 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 124 at risk

Adverse event: INTRAOCULAR PRESSURE INCREASED (Study eye)
Serious: no
Organ System: Investigations
Frequency: 7 affected / 124 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 124 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 124 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 124 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 124 at risk

Adverse event: VASCULAR SHUNT (Study eye)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 124 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 119 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 119 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 119 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 119 at risk

Adverse event: Deafness
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 119 at risk

Adverse event: CONJUNCTIVAL HYPERAEMIA (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 119 at risk

Adverse event: CORNEAL OEDEMA (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 119 at risk

Adverse event: EYE PAIN (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 119 at risk

Adverse event: GLAUCOMA (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 119 at risk

Adverse event: HYPHAEMA (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 119 at risk

Adverse event: IRIS NEOVASCULARISATION (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 4 affected / 119 at risk

Adverse event: MACULAR OEDEMA (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 119 at risk

Adverse event: RETINAL ARTERY OCCLUSION (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 119 at risk

Adverse event: RETINAL VEIN OCCLUSION (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 119 at risk

Adverse event: VISUAL ACUITY REDUCED (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 119 at risk

Adverse event: VITREOUS HAEMORRHAGE (Study eye)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 119 at risk

Adverse event: Abdominal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 119 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 119 at risk

Adverse event: Soft tissue infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 119 at risk

Adverse event: INTRAOCULAR PRESSURE DECREASED (Study eye)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 119 at risk

Adverse event: INTRAOCULAR PRESSURE INCREASED (Study eye)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 119 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 119 at risk

Adverse event: Adenocarcinoma of colon
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 119 at risk

Adverse event: Gastrointestinal carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 119 at risk

Adverse event: Renal neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 119 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 119 at risk

Adverse event: Radial nerve palsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 119 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 119 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 119 at risk

Adverse event: ABNORMAL SENSATION IN EYE (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 119 at risk

Adverse event: CONJUNCTIVAL HAEMORRHAGE (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 119 at risk

Adverse event: DRY EYE (Fellow eye)
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 119 at risk

Adverse event: DRY EYE (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 119 at risk

Adverse event: EYE IRRITATION (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 119 at risk

Adverse event: EYE PAIN (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 119 at risk

Adverse event: FOREIGN BODY SENSATION IN EYES (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 119 at risk

Adverse event: GLAUCOMA (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 119 at risk

Adverse event: IRIS NEOVASCULARISATION (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 119 at risk

Adverse event: LACRIMATION INCREASED (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 119 at risk

Adverse event: MACULAR ISCHAEMIA (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 119 at risk

Adverse event: MACULAR OEDEMA (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 19 affected / 119 at risk

Adverse event: OCULAR HYPERAEMIA (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 15 affected / 119 at risk

Adverse event: OCULAR HYPERTENSION (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 119 at risk

Adverse event: RETINAL EXUDATES (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 119 at risk

Adverse event: RETINAL ISCHAEMIA (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 119 at risk

Adverse event: RETINAL VASCULAR DISORDER (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 119 at risk

Adverse event: VISUAL ACUITY REDUCED (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 19 affected / 119 at risk

Adverse event: VISUAL IMPAIRMENT (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 119 at risk

Adverse event: VITREOUS DETACHMENT (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 119 at risk

Adverse event: VITREOUS FLOATERS (Study eye)
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 119 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 119 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 119 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 119 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 119 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 119 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 119 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 119 at risk

Adverse event: INTRAOCULAR PRESSURE INCREASED (Fellow eye)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 119 at risk

Adverse event: INTRAOCULAR PRESSURE INCREASED (Study eye)
Serious: no
Organ System: Investigations
Frequency: 38 affected / 119 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 119 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 119 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 119 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 119 at risk

Adverse event: VASCULAR SHUNT (Study eye)
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 119 at risk