Study: NCT00367133

Adverse event: Abdominal discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 330 at risk

Adverse event: Abdominal hernia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 330 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 330 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 330 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 330 at risk

Adverse event: Allergy to arthropod bite
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 330 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 330 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 330 at risk

Adverse event: Angioplasty
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 330 at risk

Adverse event: Arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 330 at risk

Adverse event: Arteriosclerosis coronary artery
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 330 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 330 at risk

Adverse event: Asbestosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 330 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 330 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 330 at risk

Adverse event: Bladder transitional cell carcinoma
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 330 at risk

Adverse event: Blindness
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 330 at risk

Adverse event: Full blood count abnormal
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 330 at risk

Adverse event: Blood electrolytes decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 330 at risk

Adverse event: Blood glucose abnormal
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 330 at risk

Adverse event: Blood glucose decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 330 at risk

Adverse event: Blood glucose increased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 330 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 330 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 330 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 330 at risk

Adverse event: Bronchitis viral
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 330 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 330 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 330 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 330 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 330 at risk

Adverse event: Carotid artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 330 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 330 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 330 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 330 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 330 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 330 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 330 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 330 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 330 at risk

Adverse event: Colonoscopy abnormal
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 330 at risk

Adverse event: Colostomy closure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 330 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 330 at risk

Adverse event: Seizure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 330 at risk

Adverse event: Coronary arterial stent insertion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 330 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 330 at risk

Adverse event: Crohn's disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 330 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 330 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 330 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 330 at risk

Adverse event: Dementia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 330 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 330 at risk

Adverse event: Diabetic coma
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 330 at risk

Adverse event: Diabetic complications
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 330 at risk

Adverse event: Diabetic retinopathy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 330 at risk

Adverse event: Dialysis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 330 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 330 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 330 at risk

Adverse event: Diverticulum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 330 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 330 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 330 at risk

Adverse event: Endarterectomy
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 330 at risk

Adverse event: Epididymitis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 330 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 330 at risk

Adverse event: Fall
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 330 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 330 at risk

Adverse event: Gastric bypass
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 330 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 330 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 330 at risk

Adverse event: Gastrointestinal infection
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 330 at risk

Adverse event: Gastrointestinal injury
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 330 at risk

Adverse event: Generalised oedema
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 330 at risk

Adverse event: Gout
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 330 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 330 at risk

Adverse event: Haemolytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 330 at risk

Adverse event: Head injury
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 330 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 330 at risk

Adverse event: Heart rate increased
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 330 at risk

Adverse event: Heart rate irregular
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 330 at risk

Adverse event: Hernia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 330 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 330 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 330 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 330 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 330 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 330 at risk

Adverse event: Hyperparathyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 330 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 330 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 330 at risk

Adverse event: Iliac artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 330 at risk

Adverse event: Impaired gastric emptying
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 330 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 330 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 330 at risk

Adverse event: Joint swelling
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 330 at risk

Adverse event: Kidney infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 330 at risk

Adverse event: Knee arthroplasty
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 330 at risk

Adverse event: Limb injury
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 330 at risk

Adverse event: Limb operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 330 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 330 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 330 at risk

Adverse event: Lumbar spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 330 at risk

Adverse event: Meniscus injury
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 330 at risk

Adverse event: Mental disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 330 at risk

Adverse event: Metatarsal excision
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 330 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 330 at risk

Adverse event: Nephropathy toxic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 330 at risk

Adverse event: Nephrotic syndrome
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 330 at risk

Adverse event: Normochromic normocytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 330 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 330 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 330 at risk

Adverse event: Oesophageal carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 330 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 330 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 330 at risk

Adverse event: Ovarian cancer
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 330 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 330 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 330 at risk

Adverse event: Pelvic fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 330 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 330 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 330 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 330 at risk

Adverse event: Post procedural infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 330 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 330 at risk

Adverse event: Prostate examination abnormal
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 330 at risk

Adverse event: Pseudomonas infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 330 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 330 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 330 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 330 at risk

Adverse event: Pulse absent
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 330 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 330 at risk

Adverse event: Renal disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 330 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 330 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 330 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 330 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 330 at risk

Adverse event: Renal transplant
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 330 at risk

Adverse event: Renal vessel disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 330 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 330 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 330 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 330 at risk

Adverse event: Shunt malfunction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 330 at risk

Adverse event: Skin bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 330 at risk

Adverse event: Skin lesion removal
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 330 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 330 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 330 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 330 at risk

Adverse event: Stent placement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 330 at risk

Adverse event: Surgical vascular shunt
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 330 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 330 at risk

Adverse event: Tobacco abuse
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 330 at risk

Adverse event: Toe amputation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 330 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 330 at risk

Adverse event: Urinary incontinence
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 330 at risk

Adverse event: Urinary tract disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 330 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 330 at risk

Adverse event: Vascular dementia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 330 at risk

Adverse event: Vertigo
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 330 at risk

Adverse event: Visual acuity reduced
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 330 at risk

Adverse event: Vitrectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 330 at risk

Adverse event: Vitreous floaters
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 330 at risk

Adverse event: Volvulus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 330 at risk

Adverse event: Wound infection staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 330 at risk

Adverse event: Anterior chamber cell
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 330 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 38 affected / 330 at risk

Adverse event: Cataract cortical
Serious: no
Organ System: Eye disorders
Frequency: 19 affected / 330 at risk

Adverse event: Cataract nuclear
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 330 at risk

Adverse event: Cataract operation
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 330 at risk

Adverse event: Cataract subcapsular
Serious: no
Organ System: Eye disorders
Frequency: 29 affected / 330 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 330 at risk

Adverse event: Diabetic retinopathy
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 330 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 330 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 330 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 330 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 330 at risk

Adverse event: Foreign body in the eye
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 330 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 330 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 330 at risk

Adverse event: Maculopathy
Serious: no
Organ System: Eye disorders
Frequency: 23 affected / 330 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 36 affected / 330 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 47 affected / 330 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 15 affected / 330 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Frequency: 16 affected / 330 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 36 affected / 330 at risk

Adverse event: Vitrous Hemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 49 affected / 330 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 21 affected / 330 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 19 affected / 330 at risk

Adverse event: Dysonoea
Serious: no
Organ System: General disorders
Frequency: 15 affected / 330 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 15 affected / 330 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 11 affected / 330 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 17 affected / 330 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 14 affected / 330 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 14 affected / 330 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 256 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 256 at risk

Adverse event: Arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 256 at risk

Adverse event: Arteriosclerosis coronary artery
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 256 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 256 at risk

Adverse event: Blood electrolytes decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 256 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 256 at risk

Adverse event: Bronchitis viral
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 256 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 256 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 256 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 256 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 256 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 256 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 256 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 256 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 256 at risk

Adverse event: Diabetic coma
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 256 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 256 at risk

Adverse event: Diverticulum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 256 at risk

Adverse event: Dizziness
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 256 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 256 at risk

Adverse event: Epididymitis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 256 at risk

Adverse event: Gastrointestinal injury
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 256 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 256 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 256 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 256 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 256 at risk

Adverse event: Iliac artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 256 at risk

Adverse event: Kidney infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 256 at risk

Adverse event: Limb injury
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 256 at risk

Adverse event: Limb operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 256 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 256 at risk

Adverse event: Meniscus injury
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 256 at risk

Adverse event: Mental disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 256 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 256 at risk

Adverse event: Normochromic normocytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 256 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 256 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 256 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 256 at risk

Adverse event: Ovarian cancer
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 256 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 256 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 256 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 256 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 256 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 256 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 256 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 256 at risk

Adverse event: Renal vessel disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 256 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 256 at risk

Adverse event: Shunt malfunction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 256 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 256 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 256 at risk

Adverse event: Surgical vascular shunt
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 256 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 256 at risk

Adverse event: Volvulus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 256 at risk

Adverse event: Anterior chamber cell
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 256 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 29 affected / 256 at risk

Adverse event: Cataract cortical
Serious: no
Organ System: Eye disorders
Frequency: 22 affected / 256 at risk

Adverse event: Cataract nuclear
Serious: no
Organ System: Eye disorders
Frequency: 30 affected / 256 at risk

Adverse event: Cataract operation
Serious: no
Organ System: Eye disorders
Frequency: 16 affected / 256 at risk

Adverse event: Cataract subcapsular
Serious: no
Organ System: Eye disorders
Frequency: 54 affected / 256 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 96 affected / 256 at risk

Adverse event: Diabetic retinopathy
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 256 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 256 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 256 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 28 affected / 256 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 256 at risk

Adverse event: Foreign body in the eye
Serious: no
Organ System: Eye disorders
Frequency: 61 affected / 256 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Eye disorders
Frequency: 50 affected / 256 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 19 affected / 256 at risk

Adverse event: Maculopathy
Serious: no
Organ System: Eye disorders
Frequency: 31 affected / 256 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 44 affected / 256 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 40 affected / 256 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 23 affected / 256 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 256 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 92 affected / 256 at risk

Adverse event: Vitrous Hemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 43 affected / 256 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 256 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 17 affected / 256 at risk

Adverse event: Dysonoea
Serious: no
Organ System: General disorders
Frequency: 13 affected / 256 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 11 affected / 256 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 256 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 256 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 13 affected / 256 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 13 affected / 256 at risk

Adverse event: Abdominal discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 254 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 254 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 254 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 254 at risk

Adverse event: Asbestosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 254 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 254 at risk

Adverse event: Blood glucose decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 254 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 254 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 254 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 254 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 254 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 254 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 254 at risk

Adverse event: Crohn's disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 254 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 254 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 254 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 254 at risk

Adverse event: Endarterectomy
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 254 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 254 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 254 at risk

Adverse event: Gastrointestinal infection
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 254 at risk

Adverse event: Generalised oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 254 at risk

Adverse event: Gout
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 254 at risk

Adverse event: Haemolytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 254 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 254 at risk

Adverse event: Hernia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 254 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 254 at risk

Adverse event: Limb injury
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 254 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 254 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 254 at risk

Adverse event: Nephropathy toxic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 254 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 254 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 254 at risk

Adverse event: Prostate examination abnormal
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 254 at risk

Adverse event: Pseudomonas infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 254 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 254 at risk

Adverse event: Renal transplant
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 254 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 254 at risk

Adverse event: Stent placement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 254 at risk

Adverse event: Tobacco abuse
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 254 at risk

Adverse event: Anterior chamber cell
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 254 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 57 affected / 254 at risk

Adverse event: Cataract cortical
Serious: no
Organ System: Eye disorders
Frequency: 32 affected / 254 at risk

Adverse event: Cataract nuclear
Serious: no
Organ System: Eye disorders
Frequency: 38 affected / 254 at risk

Adverse event: Cataract operation
Serious: no
Organ System: Eye disorders
Frequency: 31 affected / 254 at risk

Adverse event: Cataract subcapsular
Serious: no
Organ System: Eye disorders
Frequency: 75 affected / 254 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 105 affected / 254 at risk

Adverse event: Diabetic retinopathy
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 254 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 254 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 15 affected / 254 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 33 affected / 254 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 254 at risk

Adverse event: Foreign body in the eye
Serious: no
Organ System: Eye disorders
Frequency: 51 affected / 254 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Eye disorders
Frequency: 97 affected / 254 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 16 affected / 254 at risk

Adverse event: Maculopathy
Serious: no
Organ System: Eye disorders
Frequency: 31 affected / 254 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 48 affected / 254 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 51 affected / 254 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 22 affected / 254 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Frequency: 7 affected / 254 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Frequency: 98 affected / 254 at risk

Adverse event: Vitrous Hemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 32 affected / 254 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 254 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 254 at risk

Adverse event: Dysonoea
Serious: no
Organ System: General disorders
Frequency: 16 affected / 254 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 20 affected / 254 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 254 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 21 affected / 254 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 8 affected / 254 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 254 at risk