Study: NCT00509795

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 304 at risk

Adverse event: Coagulopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 304 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 304 at risk

Adverse event: Arthropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 304 at risk

Adverse event: Lumbar spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 304 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 304 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 304 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 304 at risk

Adverse event: Spinal osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 304 at risk

Adverse event: Spondylolisthesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 304 at risk

Adverse event: Atypical fibroxanthoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: B-cell lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: Brain neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: COLON Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: HEPATIC Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTATIC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: Hepatic cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: Lung neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 304 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: Oesophageal adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: PROSTATE Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: SMALL CELL LUNG Neoplasms benign,malignant & unspecified(incl cysts and polyps)STAGE UNSPECIFIED
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: SQUAMOUS CELL CARCINOMA OF Skin and subcutaneous tissue disorders
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 304 at risk

Adverse event: Tumour haemorrhage
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: Waldenstrom's macroglobulinaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 304 at risk

Adverse event: Aortic aneurysm rupture
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 304 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 304 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 304 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 304 at risk

Adverse event: Lymphatic fistula
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 304 at risk

Adverse event: Lymphocele
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 304 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 304 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 304 at risk

Adverse event: Abdominal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Large intestine polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Duodenal ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 304 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Food poisoning
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Gastritis erosive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 304 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 304 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 304 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 304 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 304 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 304 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 304 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 304 at risk

Adverse event: Cardiac failure chronic
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 304 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 304 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 304 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 5 affected / 304 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 304 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 304 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 6 affected / 304 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 304 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 304 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 304 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 304 at risk

Adverse event: Bacterial disease carrier
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 304 at risk

Adverse event: DEVICE RELATED Infections and infestationsION
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: ESCHERICHIA URINARY TRACT Infections and infestationsION
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Klebsiella bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 304 at risk

Adverse event: LUNG Infections and infestationsION
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 304 at risk

Adverse event: Scrotal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: URINARY TRACT Infections and infestationsION
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Viral pericarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Cervical vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 304 at risk

Adverse event: Fibula fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Lumbar vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Pelvic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 304 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 304 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 304 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 304 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 304 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 304 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 304 at risk

Adverse event: Portal vein thrombosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 304 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 304 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 304 at risk

Adverse event: Cerebellar infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 304 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 304 at risk

Adverse event: Coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 304 at risk

Adverse event: Embolic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 304 at risk

Adverse event: Lacunar infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 304 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 304 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 304 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Apnoeic attack
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 304 at risk

Adverse event: Emphysema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Pulmonary mass
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Choroidal neovascularisation
Serious: yes
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 1 affected / 304 at risk

Adverse event: Posterior capsule opacification
Serious: yes
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 1 affected / 304 at risk

Adverse event: Visual acuity reduced
Serious: yes
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 1 affected / 304 at risk

Adverse event: Endophthalmitis
Serious: yes
Organ System: Infections and infestations
Notes: Ocular Fellow Eye disorders
Frequency: 1 affected / 304 at risk

Adverse event: Blindness transient
Serious: yes
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 1 affected / 304 at risk

Adverse event: Choroidal haemorrhage
Serious: yes
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 1 affected / 304 at risk

Adverse event: Pseudoendophthalmitis
Serious: yes
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 1 affected / 304 at risk

Adverse event: Vitreous haemorrhage
Serious: yes
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 1 affected / 304 at risk

Adverse event: Incorrect dose administered
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Ocular Study Eye disorders
Frequency: 1 affected / 304 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 304 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 304 at risk

Adverse event: Basal cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 304 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 35 affected / 304 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 304 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 304 at risk

Adverse event: Atrioventricular block first degree
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 16 affected / 304 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 304 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 304 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 304 at risk

Adverse event: UPPER RESPIRATORY TRACT Infections and infestationsION
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 304 at risk

Adverse event: URINARY TRACT Infections and infestationsION
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 304 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 19 affected / 304 at risk

Adverse event: Blood and lymphatic system disorders GLUCOSE INCREASED
Serious: no
Organ System: Investigations
Frequency: 13 affected / 304 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 304 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 304 at risk

Adverse event: Age-related macular degeneration
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 21 affected / 304 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 16 affected / 304 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 10 affected / 304 at risk

Adverse event: Choroidal neovascularisation
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 17 affected / 304 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 16 affected / 304 at risk

Adverse event: Macular degeneration
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 22 affected / 304 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 43 affected / 304 at risk

Adverse event: Retinal oedema
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 18 affected / 304 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 27 affected / 304 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 16 affected / 304 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Notes: Ocular Fellow Eye disorders
Frequency: 16 affected / 304 at risk

Adverse event: DRY Eye disorders
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 12 affected / 304 at risk

Adverse event: Eye disorders IRRITATION
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 19 affected / 304 at risk

Adverse event: Eye disorders PAIN
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 34 affected / 304 at risk

Adverse event: Eye disorders PRURITUS
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 11 affected / 304 at risk

Adverse event: FOREIGN BODY SENSATION IN Eye disordersS
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 9 affected / 304 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 11 affected / 304 at risk

Adverse event: Retinal pigment epitheliopathy
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 14 affected / 304 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 12 affected / 304 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 47 affected / 304 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 304 at risk

Adverse event: Cervical spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 304 at risk

Adverse event: Intervertebral disc degeneration
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 304 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 304 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 304 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 304 at risk

Adverse event: Bladder transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: Bladder transitional cell carcinoma recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: Bronchioloalveolar carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: Chronic lymphocytic leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: COLON Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: Lung neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: PROSTATE Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTATIC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: Renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: SMALL CELL LUNG Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTATIC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: SQUAMOUS CELL CARCINOMA OF Skin and subcutaneous tissue disorders
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 304 at risk

Adverse event: TONSIL Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 304 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 304 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 304 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 304 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 304 at risk

Adverse event: Peripheral artery aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 304 at risk

Adverse event: Phlebitis deep
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 304 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 304 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Haematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Death
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Device dislocation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 304 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 304 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 304 at risk

Adverse event: Arteriosclerosis coronary artery
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 304 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 304 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 304 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 304 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 304 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 304 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 304 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 304 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 304 at risk

Adverse event: CLOSTRIDIAL Infections and infestationsION
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 304 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: URINARY TRACT Infections and infestationsION
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 304 at risk

Adverse event: WOUND Infections and infestationsION BACTERIAL
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 304 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 304 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Failed back surgery syndrome
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Pelvic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 304 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Sternal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: TRAUMATIC BRAIN Injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Blood and lymphatic system disorders GLUCOSE INCREASED
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 304 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 304 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 304 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 304 at risk

Adverse event: Cholecystitis chronic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 304 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 304 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 304 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 304 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 304 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 304 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 304 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 304 at risk

Adverse event: Shock hypoglycaemic
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 304 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 304 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 304 at risk

Adverse event: Cerebral artery thrombosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 304 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 304 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 304 at risk

Adverse event: Ischaemic cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 304 at risk

Adverse event: Lacunar infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 304 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 304 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 304 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 304 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 304 at risk

Adverse event: Cholecystectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 304 at risk

Adverse event: Cystocele
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 304 at risk

Adverse event: Rectocele
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 304 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 304 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 304 at risk

Adverse event: Pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Visual acuity reduced
Serious: yes
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 1 affected / 304 at risk

Adverse event: Angle closure glaucoma
Serious: yes
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 1 affected / 304 at risk

Adverse event: Keratitis
Serious: yes
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 1 affected / 304 at risk

Adverse event: Retinal degeneration
Serious: yes
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 1 affected / 304 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 304 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 304 at risk

Adverse event: Basal cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 11 affected / 304 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 30 affected / 304 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 304 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 304 at risk

Adverse event: Atrioventricular block first degree
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 18 affected / 304 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 304 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 46 affected / 304 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 304 at risk

Adverse event: UPPER RESPIRATORY TRACT Infections and infestationsION
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 304 at risk

Adverse event: URINARY TRACT Infections and infestationsION
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 304 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 304 at risk

Adverse event: Blood and lymphatic system disorders GLUCOSE INCREASED
Serious: no
Organ System: Investigations
Frequency: 12 affected / 304 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 304 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 304 at risk

Adverse event: Age-related macular degeneration
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 16 affected / 304 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 18 affected / 304 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 17 affected / 304 at risk

Adverse event: Choroidal neovascularisation
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 10 affected / 304 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 17 affected / 304 at risk

Adverse event: Macular degeneration
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 14 affected / 304 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 36 affected / 304 at risk

Adverse event: Retinal oedema
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 8 affected / 304 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 10 affected / 304 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 24 affected / 304 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Notes: Ocular Fellow Eye disorders
Frequency: 8 affected / 304 at risk

Adverse event: DRY Eye disorders
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 16 affected / 304 at risk

Adverse event: Eye disorders IRRITATION
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 13 affected / 304 at risk

Adverse event: Eye disorders PAIN
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 39 affected / 304 at risk

Adverse event: Eye disorders PRURITUS
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 16 affected / 304 at risk

Adverse event: FOREIGN BODY SENSATION IN Eye disordersS
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 10 affected / 304 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 11 affected / 304 at risk

Adverse event: Retinal pigment epitheliopathy
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 18 affected / 304 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 18 affected / 304 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 49 affected / 304 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 304 at risk

Adverse event: Intervertebral disc degeneration
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 304 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 304 at risk

Adverse event: Bladder transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 304 at risk

Adverse event: BREAST Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 304 at risk

Adverse event: BREAST Neoplasms benign, malignant and unspecified (incl cysts and polyps) IN SITU
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: Cardiac myxoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: Lung squamous cell carcinoma stage II
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: METASTASES TO Hepatobiliary disorders
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: Metastases to lymph nodes
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: Metastatic neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: NON-SMALL CELL LUNG Neoplasms benign, malignant and unspecified (incl cysts and polyps) STAGE IV
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: PROSTATE Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 304 at risk

Adverse event: RECTAL Neoplasms benign, malignant and unspecified (incl cysts and polyps) STAGE III
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: SALIVARY GLAND Neoplasms benign, malignant and unspecified (incl cysts and polyps) RECURRENT
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: SMALL CELL LUNG Neoplasms benign,malignant & unspecified(incl cysts and polyps)STAGE UNSPECIFIED
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 304 at risk

Adverse event: SQUAMOUS CELL CARCINOMA OF Skin and subcutaneous tissue disorders
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 304 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 304 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 304 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 304 at risk

Adverse event: Femoral artery aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 304 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 304 at risk

Adverse event: Iliac artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 304 at risk

Adverse event: Phlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 304 at risk

Adverse event: Meniere's disease
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 304 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Colitis ischaemic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Duodenal ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Gastric haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Gastrointestinal motility disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 304 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 304 at risk

Adverse event: Asthenia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 304 at risk

Adverse event: Drug withdrawal syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 304 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 304 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 7 affected / 304 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 304 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 304 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 304 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 304 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 6 affected / 304 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 304 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 5 affected / 304 at risk

Adverse event: Tachyarrhythmia
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 304 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 304 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Anorectal cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 304 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 304 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: ESCHERICHIA URINARY TRACT Infections and infestationsION
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 304 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Sinusitis fungal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Staphylococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: URINARY TRACT Infections and infestationsION BACTERIAL
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: URINARY TRACT Infections and infestationsION STAPHYLOCOCCAL
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Vestibular neuronitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: VIRAL Infections and infestationsION
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 304 at risk

Adverse event: Accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 304 at risk

Adverse event: HEAD Injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 304 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 304 at risk

Adverse event: Procedural pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 304 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 304 at risk

Adverse event: Blood and lymphatic system disorders PRESSURE ORTHOSTATIC ABNORMAL
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 304 at risk

Adverse event: Calculus bladder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 304 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 304 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 304 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 304 at risk

Adverse event: Portal hypertension
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 304 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 304 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 304 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 304 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 304 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 304 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 304 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 304 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 304 at risk

Adverse event: Metabolic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 304 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 304 at risk

Adverse event: Spinal cord compression
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 304 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 304 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 304 at risk

Adverse event: Transient global amnesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 304 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 304 at risk

Adverse event: MICROGRAPHIC Skin and subcutaneous tissue disorders SURGERY
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 304 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 304 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 304 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 304 at risk

Adverse event: Maculopathy
Serious: yes
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 1 affected / 304 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 2 affected / 304 at risk

Adverse event: Visual acuity reduced
Serious: yes
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 3 affected / 304 at risk

Adverse event: Endophthalmitis
Serious: yes
Organ System: Infections and infestations
Notes: Ocular Fellow Eye disorders
Frequency: 1 affected / 304 at risk

Adverse event: Macular hole
Serious: yes
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 1 affected / 304 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 304 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 304 at risk

Adverse event: Basal cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 15 affected / 304 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 32 affected / 304 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 304 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 304 at risk

Adverse event: Atrioventricular block first degree
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 8 affected / 304 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 304 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 41 affected / 304 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 304 at risk

Adverse event: UPPER RESPIRATORY TRACT Infections and infestationsION
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 304 at risk

Adverse event: URINARY TRACT Infections and infestationsION
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 304 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 15 affected / 304 at risk

Adverse event: Blood and lymphatic system disorders GLUCOSE INCREASED
Serious: no
Organ System: Investigations
Frequency: 17 affected / 304 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 304 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 304 at risk

Adverse event: Age-related macular degeneration
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 12 affected / 304 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 14 affected / 304 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 10 affected / 304 at risk

Adverse event: Choroidal neovascularisation
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 13 affected / 304 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 16 affected / 304 at risk

Adverse event: Macular degeneration
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 21 affected / 304 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 36 affected / 304 at risk

Adverse event: Retinal oedema
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 12 affected / 304 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 20 affected / 304 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 25 affected / 304 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Notes: Ocular Fellow Eye disorders
Frequency: 15 affected / 304 at risk

Adverse event: DRY Eye disorders
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 10 affected / 304 at risk

Adverse event: Eye disorders IRRITATION
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 15 affected / 304 at risk

Adverse event: Eye disorders PAIN
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 35 affected / 304 at risk

Adverse event: Eye disorders PRURITUS
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 10 affected / 304 at risk

Adverse event: FOREIGN BODY SENSATION IN Eye disordersS
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 10 affected / 304 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 15 affected / 304 at risk

Adverse event: Retinal pigment epitheliopathy
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 17 affected / 304 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 17 affected / 304 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 30 affected / 304 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 303 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 303 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 303 at risk

Adverse event: Intervertebral disc degeneration
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 303 at risk

Adverse event: Lumbar spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 303 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 303 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 303 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 303 at risk

Adverse event: Bladder transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 303 at risk

Adverse event: BREAST Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 303 at risk

Adverse event: COLON Neoplasms benign, malignant and unspecified (incl cysts and polyps) RECURRENT
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 303 at risk

Adverse event: ENDOMETRIAL Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 303 at risk

Adverse event: Leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 303 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 303 at risk

Adverse event: Metastases to central nervous system
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 303 at risk

Adverse event: Metastases to lung
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 303 at risk

Adverse event: NON-SMALL CELL LUNG Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTATIC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 303 at risk

Adverse event: PROSTATE Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 303 at risk

Adverse event: PROSTATE Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTATIC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 303 at risk

Adverse event: RECTOSIGMOID Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 303 at risk

Adverse event: Renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 303 at risk

Adverse event: SQUAMOUS CELL CARCINOMA OF Skin and subcutaneous tissue disorders
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 303 at risk

Adverse event: THYROID Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 303 at risk

Adverse event: Tongue neoplasm malignant stage unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 303 at risk

Adverse event: Transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 303 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 303 at risk

Adverse event: Arteriosclerosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 303 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 303 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 303 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 303 at risk

Adverse event: Shock haemorrhagic
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 303 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 303 at risk

Adverse event: Abdominal hernia obstructive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Gastrointestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Hiatus hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Oesophageal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Catheter site haematoma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Arteriovenous malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 303 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 303 at risk

Adverse event: Aortic valve stenosis
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 303 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 7 affected / 303 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 8 affected / 303 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 303 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 303 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 303 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 303 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 303 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 303 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 303 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 303 at risk

Adverse event: Arthritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 303 at risk

Adverse event: CLOSTRIDIAL Infections and infestationsION
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 303 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Encephalitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 303 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Labyrinthitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 303 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 303 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Staphylococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 303 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 16 affected / 303 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 303 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 303 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 303 at risk

Adverse event: Incisional hernia, obstructive
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 303 at risk

Adverse event: JOINT Injury, poisoning and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 303 at risk

Adverse event: Meniscus injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 303 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 303 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 303 at risk

Adverse event: Snake bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 303 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 303 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 303 at risk

Adverse event: Subcutaneous haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 303 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 303 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 303 at risk

Adverse event: Blood and lymphatic system disorders PRESSURE INCREASED
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 303 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 303 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 303 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 303 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 303 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 303 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 303 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 303 at risk

Adverse event: Balance disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 303 at risk

Adverse event: Carotid artery disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 303 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 303 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 303 at risk

Adverse event: Dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 303 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 303 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 303 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 303 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 303 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 303 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 303 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 303 at risk

Adverse event: Psychiatric disordersOTIC DISORDER
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 303 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 303 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 303 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 303 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 303 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Restrictive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Tracheal mass
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 303 at risk

Adverse event: Conjunctivitis
Serious: yes
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 1 affected / 303 at risk

Adverse event: Retinal haemorrhage
Serious: yes
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 1 affected / 303 at risk

Adverse event: RETINAL TEar and labyrinth disorders
Serious: yes
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 1 affected / 303 at risk

Adverse event: Uveitis
Serious: yes
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 1 affected / 303 at risk

Adverse event: RETINAL PIGMENT EPITHELIAL TEar and labyrinth disorders
Serious: yes
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 1 affected / 303 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 303 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 303 at risk

Adverse event: Basal cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 17 affected / 303 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 33 affected / 303 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 303 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 303 at risk

Adverse event: Atrioventricular block first degree
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 9 affected / 303 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 303 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 39 affected / 303 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 303 at risk

Adverse event: UPPER RESPIRATORY TRACT Infections and infestationsION
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 303 at risk

Adverse event: URINARY TRACT Infections and infestationsION
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 303 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 21 affected / 303 at risk

Adverse event: Blood and lymphatic system disorders GLUCOSE INCREASED
Serious: no
Organ System: Investigations
Frequency: 16 affected / 303 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 303 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 303 at risk

Adverse event: Age-related macular degeneration
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 15 affected / 303 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 14 affected / 303 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 10 affected / 303 at risk

Adverse event: Choroidal neovascularisation
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 9 affected / 303 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 19 affected / 303 at risk

Adverse event: Macular degeneration
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 14 affected / 303 at risk

Adverse event: Retinal haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 22 affected / 303 at risk

Adverse event: Retinal oedema
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 11 affected / 303 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 19 affected / 303 at risk

Adverse event: Vitreous detachment
Serious: no
Organ System: Eye disorders
Notes: Ocular Fellow Eye disorders
Frequency: 24 affected / 303 at risk

Adverse event: Intraocular pressure increased
Serious: no
Organ System: Investigations
Notes: Ocular Fellow Eye disorders
Frequency: 15 affected / 303 at risk

Adverse event: DRY Eye disorders
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 14 affected / 303 at risk

Adverse event: Eye disorders IRRITATION
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 16 affected / 303 at risk

Adverse event: Eye disorders PAIN
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 31 affected / 303 at risk

Adverse event: Eye disorders PRURITUS
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 6 affected / 303 at risk

Adverse event: FOREIGN BODY SENSATION IN Eye disordersS
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 19 affected / 303 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 16 affected / 303 at risk

Adverse event: Retinal pigment epitheliopathy
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 14 affected / 303 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 13 affected / 303 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Notes: Ocular Study Eye disorders
Frequency: 29 affected / 303 at risk