Study: NCT01277302

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 85 at risk

Adverse event: Non-cardia chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 85 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 85 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 85 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 85 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 85 at risk

Adverse event: Muscle spasms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 85 at risk

Adverse event: Osteolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 85 at risk

Adverse event: Benign lymph node neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 85 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 85 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 85 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 85 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 85 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 85 at risk

Adverse event: Visual acuity reduced
Serious: yes
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 85 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 85 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 85 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 85 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 85 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 85 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 85 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 85 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 85 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 85 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 85 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 85 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 9 affected / 85 at risk

Adverse event: Cataract cortical
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 4 affected / 85 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 28 affected / 85 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 4 affected / 85 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 6 affected / 85 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 8 affected / 85 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 85 at risk

Adverse event: Macular fibrosis
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 9 affected / 85 at risk

Adverse event: Macular hole
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 85 at risk

Adverse event: Macular oedema
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 2 affected / 85 at risk

Adverse event: Retinal aneurysm
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 85 at risk

Adverse event: Retinal depigmentation
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 2 affected / 85 at risk

Adverse event: Retinal disorder
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 7 affected / 85 at risk

Adverse event: Retinal exudates
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 13 affected / 85 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 8 affected / 85 at risk

Adverse event: Retinal vascular disorder
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 3 affected / 85 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 11 affected / 85 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 4 affected / 85 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Notes: Study eye
Frequency: 3 affected / 85 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: Fellow eye
Frequency: 8 affected / 85 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: Fellow eye
Frequency: 3 affected / 85 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Fellow eye
Frequency: 4 affected / 85 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Notes: Fellow eye
Frequency: 7 affected / 85 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 86 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 86 at risk

Adverse event: Intestinal infarction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 86 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 86 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 86 at risk

Adverse event: Biliary dyskinesia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 86 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 86 at risk

Adverse event: Muscle spasms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 86 at risk

Adverse event: Periarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 86 at risk

Adverse event: Meningioma benign
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 86 at risk

Adverse event: Spinal cord neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 86 at risk

Adverse event: Dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 86 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 86 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 86 at risk

Adverse event: Visual acuity reduced
Serious: yes
Organ System: Eye disorders
Notes: Study eye
Frequency: 3 affected / 86 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 86 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 86 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 86 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 86 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 86 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 86 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 86 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 86 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 86 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 86 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 86 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 6 affected / 86 at risk

Adverse event: Cataract cortical
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 5 affected / 86 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 23 affected / 86 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 3 affected / 86 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 5 affected / 86 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 14 affected / 86 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 4 affected / 86 at risk

Adverse event: Macular fibrosis
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 5 affected / 86 at risk

Adverse event: Macular oedema
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 6 affected / 86 at risk

Adverse event: Retinal aneurysm
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 5 affected / 86 at risk

Adverse event: Retinal disorder
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 86 at risk

Adverse event: Retinal exudates
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 12 affected / 86 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 8 affected / 86 at risk

Adverse event: Retinal vascular disorder
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 5 affected / 86 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 6 affected / 86 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 6 affected / 86 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Notes: Study eye
Frequency: 8 affected / 86 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: Fellow eye
Frequency: 5 affected / 86 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: Fellow eye
Frequency: 2 affected / 86 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Fellow eye
Frequency: 6 affected / 86 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Notes: Fellow eye
Frequency: 2 affected / 86 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 31 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Neck injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 31 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Pathological fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Lung adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 31 at risk

Adverse event: Lung cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 31 at risk

Adverse event: Squamous cell carcinoma of lung
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 31 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 31 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 31 at risk

Adverse event: Macular hole
Serious: yes
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 31 at risk

Adverse event: Macular oedema
Serious: yes
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 31 at risk

Adverse event: Iridocyclitis
Serious: yes
Organ System: Eye disorders
Notes: Fellow eye
Frequency: 1 affected / 31 at risk

Adverse event: Visual acuity reduced
Serious: yes
Organ System: Eye disorders
Notes: Fellow eye
Frequency: 1 affected / 31 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 31 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 31 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 31 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 31 at risk

Adverse event: Diabetic neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 31 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 31 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 31 at risk

Adverse event: Cataract cortical
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 31 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 9 affected / 31 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 2 affected / 31 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 31 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 4 affected / 31 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 2 affected / 31 at risk

Adverse event: Macular fibrosis
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 2 affected / 31 at risk

Adverse event: Macular hole
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 2 affected / 31 at risk

Adverse event: Macular oedema
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 31 at risk

Adverse event: Retinal depigmentation
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 2 affected / 31 at risk

Adverse event: Retinal disorder
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 31 at risk

Adverse event: Retinal exudates
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 3 affected / 31 at risk

Adverse event: Vitreous adhesions
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 3 affected / 31 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 3 affected / 31 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Notes: Study eye
Frequency: 1 affected / 31 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Notes: Study eye
Frequency: 1 affected / 31 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: Fellow eye
Frequency: 2 affected / 31 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Notes: Fellow eye
Frequency: 1 affected / 31 at risk