Study: NCT02807857

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1415 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1415 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 1415 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 29 affected / 1415 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1415 at risk

Adverse event: Cardiac failure chronic
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1415 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1415 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Ventricular extrasystoles
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1415 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Gastric haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1415 at risk

Adverse event: Melaena
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Short-bowel syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1415 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1415 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Soft tissue inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Sudden cardiac death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Ulcer haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1415 at risk

Adverse event: Epididymitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1415 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1415 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1415 at risk

Adverse event: Intestinal gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1415 at risk

Adverse event: Orchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1415 at risk

Adverse event: Otitis externa
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1415 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 1415 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1415 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1415 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1415 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1415 at risk

Adverse event: Electric shock
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1415 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1415 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1415 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1415 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1415 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1415 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1415 at risk

Adverse event: International normalised ratio increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1415 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 1415 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Lumbar spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Brain neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1415 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1415 at risk

Adverse event: Neuroendocrine tumour
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1415 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 1415 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 1415 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 1415 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 1415 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Endometrial hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Uterovaginal prolapse
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1415 at risk

Adverse event: Dyspnoea exertional
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Orthopnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Pulmonary mass
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1415 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Ischaemic skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Homicide
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 1415 at risk

Adverse event: Aortic valve repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1415 at risk

Adverse event: Cardiac ablation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1415 at risk

Adverse event: Cardiac pacemaker insertion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1415 at risk

Adverse event: Cardiac resynchronisation therapy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1415 at risk

Adverse event: Cardioversion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1415 at risk

Adverse event: Circulatory collapse
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Peripheral artery thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Vasculitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 1415 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Arteriosclerosis coronary artery
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 1415 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 1415 at risk

Adverse event: Cardio-respiratory arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Hypertensive cardiomyopathy
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1415 at risk

Adverse event: Tachyarrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 6 affected / 1415 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Accommodation disorder
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 1415 at risk

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Sudden visual loss
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1415 at risk

Adverse event: Abdominal wall haematoma
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Anal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Cheilitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 1415 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1415 at risk

Adverse event: Enterocolitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Functional gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Gastric ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1415 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Gastrointestinal angiodysplasia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1415 at risk

Adverse event: Inguinal hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Melaena
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1415 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1415 at risk

Adverse event: Adverse drug reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 1415 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 9 affected / 1415 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 8 affected / 1415 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Thirst
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Hepatic cirrhosis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 1415 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1415 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1415 at risk

Adverse event: Erysipelas
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1415 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1415 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1415 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1415 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1415 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 1415 at risk

Adverse event: Onychomycosis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1415 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1415 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1415 at risk

Adverse event: Pulpitis dental
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1415 at risk

Adverse event: Pyuria
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1415 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1415 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1415 at risk

Adverse event: Tracheobronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1415 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 1415 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 1415 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1415 at risk

Adverse event: Viral sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1415 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1415 at risk

Adverse event: Epicondylitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1415 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1415 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1415 at risk

Adverse event: Rib fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1415 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1415 at risk

Adverse event: Blood creatinine abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1415 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 1415 at risk

Adverse event: Blood iron decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1415 at risk

Adverse event: Blood pressure abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1415 at risk

Adverse event: Blood pressure diastolic increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1415 at risk

Adverse event: Haemoglobin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1415 at risk

Adverse event: N-terminal prohormone brain natriuretic peptide increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1415 at risk

Adverse event: Prostatic specific antigen increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1415 at risk

Adverse event: Vitamin B12 decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1415 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1415 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 1415 at risk

Adverse event: Diabetic metabolic decompensation
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1415 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 1415 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1415 at risk

Adverse event: Obesity
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 1415 at risk

Adverse event: Type 2 diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1415 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1415 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 1415 at risk

Adverse event: Cervical spinal stenosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Gouty arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1415 at risk

Adverse event: Joint range of motion decreased
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Osteitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1415 at risk

Adverse event: Rotator cuff syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Spinal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Temporomandibular pain and dysfunction syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Tendon disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1415 at risk

Adverse event: Torticollis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Breast cancer
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1415 at risk

Adverse event: Squamous cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1415 at risk

Adverse event: Carotid artery stenosis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Cervical radiculopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 1415 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 1415 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Leukoencephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 1415 at risk

Adverse event: Anxiety disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 1415 at risk

Adverse event: Bipolar disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 1415 at risk

Adverse event: Hallucination, visual
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Nightmare
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1415 at risk

Adverse event: Nephropathy
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1415 at risk

Adverse event: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1415 at risk

Adverse event: Renal colic
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 1415 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Bronchiectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Catarrh
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1415 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 1415 at risk

Adverse event: Chronic respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 1415 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1415 at risk

Adverse event: Dyspnoea at rest
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1415 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 1415 at risk

Adverse event: Dyspnoea paroxysmal nocturnal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1415 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1415 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Nocturnal dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1415 at risk

Adverse event: Orthopnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1415 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1415 at risk

Adverse event: Rales
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1415 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1415 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1415 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Ingrowing nail
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 1415 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1415 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Cataract operation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1415 at risk

Adverse event: Coronary angioplasty
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1415 at risk

Adverse event: Dental operation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1415 at risk

Adverse event: Intraocular lens implant
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1415 at risk

Adverse event: Aortic aneurysm
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 1415 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 1415 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Peripheral vascular disorder
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Thrombophlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Varicose vein
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Venous thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1415 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 861 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 861 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 861 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 861 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 861 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 861 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 861 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 861 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 27 affected / 861 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 861 at risk

Adverse event: Cardiac failure chronic
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 861 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 861 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 861 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 861 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 861 at risk

Adverse event: Ventricular extrasystoles
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 861 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 861 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 861 at risk

Adverse event: Gastric haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 861 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 861 at risk

Adverse event: Melaena
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 861 at risk

Adverse event: Short-bowel syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 861 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 861 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 861 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 861 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 861 at risk

Adverse event: Soft tissue inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 861 at risk

Adverse event: Sudden cardiac death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 861 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 861 at risk

Adverse event: Ulcer haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 861 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 861 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 861 at risk

Adverse event: Epididymitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 861 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 861 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 861 at risk

Adverse event: Intestinal gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 861 at risk

Adverse event: Orchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 861 at risk

Adverse event: Otitis externa
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 861 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 861 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 861 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 861 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 861 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 861 at risk

Adverse event: Electric shock
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 861 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 861 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 861 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 861 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 861 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 861 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 861 at risk

Adverse event: International normalised ratio increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 861 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 861 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 861 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 861 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 861 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 861 at risk

Adverse event: Lumbar spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 861 at risk

Adverse event: Brain neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 861 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 861 at risk

Adverse event: Neuroendocrine tumour
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 861 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 861 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 861 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 861 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 861 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 861 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 861 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 861 at risk

Adverse event: Endometrial hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 861 at risk

Adverse event: Uterovaginal prolapse
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 861 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 861 at risk

Adverse event: Dyspnoea exertional
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 861 at risk

Adverse event: Orthopnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 861 at risk

Adverse event: Pulmonary mass
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 861 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 861 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 861 at risk

Adverse event: Ischaemic skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 861 at risk

Adverse event: Homicide
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 861 at risk

Adverse event: Aortic valve repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 861 at risk

Adverse event: Cardiac ablation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 861 at risk

Adverse event: Cardiac pacemaker insertion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 861 at risk

Adverse event: Cardiac resynchronisation therapy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 861 at risk

Adverse event: Cardioversion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 861 at risk

Adverse event: Circulatory collapse
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 861 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 861 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 861 at risk

Adverse event: Peripheral artery thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 861 at risk

Adverse event: Vasculitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 861 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 861 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 861 at risk

Adverse event: Arteriosclerosis coronary artery
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 861 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 861 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 861 at risk

Adverse event: Cardio-respiratory arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 861 at risk

Adverse event: Hypertensive cardiomyopathy
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 861 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 861 at risk

Adverse event: Tachyarrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 861 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 861 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 861 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 6 affected / 861 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 861 at risk

Adverse event: Accommodation disorder
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 861 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 861 at risk

Adverse event: Diplopia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 861 at risk

Adverse event: Sudden visual loss
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 861 at risk

Adverse event: Visual acuity reduced
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 861 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 861 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 861 at risk

Adverse event: Abdominal wall haematoma
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 861 at risk

Adverse event: Anal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 861 at risk

Adverse event: Cheilitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 861 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 861 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 861 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 861 at risk

Adverse event: Enterocolitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 861 at risk

Adverse event: Functional gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 861 at risk

Adverse event: Gastric ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 861 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 861 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 861 at risk

Adverse event: Gastrointestinal angiodysplasia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 861 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 861 at risk

Adverse event: Inguinal hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 861 at risk

Adverse event: Melaena
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 861 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 861 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 861 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 861 at risk

Adverse event: Adverse drug reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 861 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 861 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 9 affected / 861 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 861 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 861 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 8 affected / 861 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 861 at risk

Adverse event: Thirst
Serious: no
Organ System: General disorders
Frequency: 1 affected / 861 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 861 at risk

Adverse event: Hepatic cirrhosis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 861 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 861 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 861 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 861 at risk

Adverse event: Erysipelas
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 861 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 861 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 861 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 861 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 861 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 861 at risk

Adverse event: Onychomycosis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 861 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 861 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 861 at risk

Adverse event: Pulpitis dental
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 861 at risk

Adverse event: Pyuria
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 861 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 861 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 861 at risk

Adverse event: Tracheobronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 861 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 861 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 861 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 861 at risk

Adverse event: Viral sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 861 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 861 at risk

Adverse event: Epicondylitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 861 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 861 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 861 at risk

Adverse event: Rib fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 861 at risk

Adverse event: Blood creatine phosphokinase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 861 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 861 at risk

Adverse event: Blood iron decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 861 at risk

Adverse event: Blood pressure abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 861 at risk

Adverse event: Blood pressure diastolic increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 861 at risk

Adverse event: Haemoglobin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 861 at risk

Adverse event: N-terminal prohormone brain natriuretic peptide increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 861 at risk

Adverse event: Prostatic specific antigen increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 861 at risk

Adverse event: Vitamin B12 decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 861 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 861 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 861 at risk

Adverse event: Diabetic metabolic decompensation
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 861 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 861 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 861 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 861 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 861 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 861 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 861 at risk

Adverse event: Obesity
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 861 at risk

Adverse event: Type 2 diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 861 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 861 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 861 at risk

Adverse event: Cervical spinal stenosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 861 at risk

Adverse event: Gouty arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 861 at risk

Adverse event: Joint range of motion decreased
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 861 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 861 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 861 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 861 at risk

Adverse event: Osteitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 861 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 861 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 861 at risk

Adverse event: Rotator cuff syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 861 at risk

Adverse event: Spinal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 861 at risk

Adverse event: Temporomandibular pain and dysfunction syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 861 at risk

Adverse event: Tendon disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 861 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 861 at risk

Adverse event: Torticollis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 861 at risk

Adverse event: Breast cancer
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 861 at risk

Adverse event: Squamous cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 861 at risk

Adverse event: Carotid artery stenosis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 861 at risk

Adverse event: Cervical radiculopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 861 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 861 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 861 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 861 at risk

Adverse event: Leukoencephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 861 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 861 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 861 at risk

Adverse event: Anxiety disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 861 at risk

Adverse event: Bipolar disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 861 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 861 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 861 at risk

Adverse event: Hallucination, visual
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 861 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 861 at risk

Adverse event: Nightmare
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 861 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 861 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 861 at risk

Adverse event: Nephropathy
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 861 at risk

Adverse event: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 861 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 861 at risk

Adverse event: Renal colic
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 861 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 861 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 861 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 861 at risk

Adverse event: Bronchiectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 861 at risk

Adverse event: Catarrh
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 861 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 861 at risk

Adverse event: Chronic respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 861 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 861 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 861 at risk

Adverse event: Dyspnoea at rest
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 861 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 861 at risk

Adverse event: Dyspnoea paroxysmal nocturnal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 861 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 861 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 861 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 861 at risk

Adverse event: Nocturnal dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 861 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 861 at risk

Adverse event: Orthopnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 861 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 861 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 861 at risk

Adverse event: Rales
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 861 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 861 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 861 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 861 at risk

Adverse event: Decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 861 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 861 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 861 at risk

Adverse event: Ingrowing nail
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 861 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 861 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 861 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 861 at risk

Adverse event: Cataract operation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 861 at risk

Adverse event: Coronary angioplasty
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 861 at risk

Adverse event: Dental operation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 861 at risk

Adverse event: Intraocular lens implant
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 861 at risk

Adverse event: Aortic aneurysm
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 861 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 861 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 861 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 861 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 861 at risk

Adverse event: Peripheral vascular disorder
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 861 at risk

Adverse event: Thrombophlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 861 at risk

Adverse event: Varicose vein
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 861 at risk

Adverse event: Venous thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 861 at risk