Study: NCT01080209

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 28 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 28 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 28 at risk

Adverse event: Age-related macular degeneration
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 28 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Cystocele
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 19 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 28 at risk

Adverse event: Enterocele
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Lung cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 28 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 28 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 28 at risk

Adverse event: Rectocele
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 19 at risk

Adverse event: Sudden cardiac death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 28 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 28 at risk

Adverse event: Visual acuity reduced
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 28 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 28 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 28 at risk

Adverse event: Age-related macular degeneration
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 28 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 28 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 28 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 28 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 28 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 28 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 28 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 28 at risk

Adverse event: Dementia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 28 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 53 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 53 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 53 at risk

Adverse event: Atrioventricular block second degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 53 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 53 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 53 at risk

Adverse event: Dyspnoea exertional
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 53 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 29 at risk

Adverse event: Rectal adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 53 at risk

Adverse event: Retinal vein occlusion
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 53 at risk

Adverse event: Optic atrophy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 53 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 53 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 53 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 53 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 53 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 53 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 53 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 53 at risk

Adverse event: Macular fibrosis
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 53 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 53 at risk

Adverse event: Optic disc haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 53 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 53 at risk

Adverse event: Glaucoma
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 53 at risk

Adverse event: Macular degeneration
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 53 at risk

Adverse event: Cataract Subscapular
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 53 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 33 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 33 at risk

Adverse event: Anterior chamber inflammation
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 33 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 33 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 33 at risk

Adverse event: Non-Hodgkin's lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 33 at risk

Adverse event: Open angle glaucoma
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 33 at risk

Adverse event: Peripheral artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 33 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 33 at risk

Adverse event: Age-related macular degeneration
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 33 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 33 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 33 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 33 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 33 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 33 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 33 at risk

Adverse event: Optic disc haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 33 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 33 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 33 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 33 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 42 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 42 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 42 at risk

Adverse event: Hepatocellular carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 42 at risk

Adverse event: Lumbar spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 42 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 42 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 42 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 22 at risk

Adverse event: Renal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 42 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 42 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 42 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 42 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 42 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 42 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 42 at risk

Adverse event: Macular fibrosis
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 42 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 42 at risk

Adverse event: Glaucoma
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 42 at risk

Adverse event: Benign prostatic hyperplasia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 22 at risk

Adverse event: Cataract cortical
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 42 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 42 at risk

Adverse event: Prostate cancer recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Acute coronary syndrome
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 6 at risk

Adverse event: Otitis media chronic
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Restless legs syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Stress urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 2 at risk

Adverse event: Glare
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 2 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 51 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 51 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 51 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 51 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 51 at risk

Adverse event: Bladder transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 51 at risk

Adverse event: Breast cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 51 at risk

Adverse event: Colorectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 51 at risk

Adverse event: Craniofacial fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 51 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 51 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 51 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 51 at risk

Adverse event: Jaw fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 51 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 51 at risk

Adverse event: Oesophageal carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 51 at risk

Adverse event: Oesophagitis ulcerative
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 51 at risk

Adverse event: Pelvic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 51 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 51 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 51 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 51 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 51 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 51 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 51 at risk

Adverse event: Posterior capsule opacification
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 51 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 51 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 51 at risk

Adverse event: Glaucoma
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 51 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 51 at risk