Study: NCT02489318

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 527 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 527 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 527 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 527 at risk

Adverse event: Cardiac amyloidosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 527 at risk

Adverse event: Cardiac disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 527 at risk

Adverse event: Cardiac failure chronic
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 527 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 527 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 527 at risk

Adverse event: Hyperparathyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 527 at risk

Adverse event: Open angle glaucoma
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 527 at risk

Adverse event: Anal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 527 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 527 at risk

Adverse event: Dyschezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 527 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 527 at risk

Adverse event: Gastric ulcer perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 527 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 527 at risk

Adverse event: Exercise tolerance decreased
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 527 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 527 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 527 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 527 at risk

Adverse event: Peripheral swelling
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 527 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 527 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 527 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 527 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 527 at risk

Adverse event: Abdominal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 527 at risk

Adverse event: Abscess jaw
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 527 at risk

Adverse event: Abscess oral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 527 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 527 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 527 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 527 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 527 at risk

Adverse event: Fournier's gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 527 at risk

Adverse event: Infected lymphocele
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 527 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 527 at risk

Adverse event: Kidney infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 527 at risk

Adverse event: Klebsiella infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 527 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 527 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 527 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 527 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 527 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 527 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 527 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 527 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 527 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 527 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 527 at risk

Adverse event: Viral upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 527 at risk

Adverse event: Acetabulum fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 527 at risk

Adverse event: Brain contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 527 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 527 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 527 at risk

Adverse event: Incisional hernia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 527 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 527 at risk

Adverse event: Radius fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 527 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 527 at risk

Adverse event: Soft tissue injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 527 at risk

Adverse event: Subdural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 527 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 527 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 527 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 527 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 527 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 527 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 527 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 527 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 527 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 527 at risk

Adverse event: Lumbar spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 527 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 527 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 527 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 527 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 527 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 527 at risk

Adverse event: Pathological fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 527 at risk

Adverse event: Rotator cuff syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 527 at risk

Adverse event: Benign lung neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 527 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 527 at risk

Adverse event: Cancer pain
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 527 at risk

Adverse event: Gastric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 527 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 527 at risk

Adverse event: Meningioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 527 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 / 527 at risk

Adverse event: Non-small cell lung cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 527 at risk

Adverse event: Cauda equina syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 527 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 527 at risk

Adverse event: Diplegia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 527 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 527 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 527 at risk

Adverse event: Paraplegia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 527 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 527 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 527 at risk

Adverse event: Spinal cord compression
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 527 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 527 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 527 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 527 at risk

Adverse event: Bladder perforation
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 527 at risk

Adverse event: Bladder tamponade
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 527 at risk

Adverse event: Calculus bladder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 527 at risk

Adverse event: Calculus urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 527 at risk

Adverse event: Dysuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 527 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 527 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 527 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 527 at risk

Adverse event: Renal disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 527 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 527 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 527 at risk

Adverse event: Urethral stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 527 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 9 affected / 527 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 527 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 527 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 527 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 527 at risk

Adverse event: Pleuritic pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 527 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 527 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 527 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 527 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 527 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 71 affected / 527 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 21 affected / 527 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 527 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 527 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 527 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 527 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 527 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 57 affected / 527 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 527 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 527 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 44 affected / 527 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 527 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 527 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 45 affected / 527 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 87 affected / 527 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 17 affected / 527 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 41 affected / 527 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 16 affected / 527 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 527 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 527 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 527 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 527 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 47 affected / 527 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 527 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 527 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 527 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 527 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 36 affected / 527 at risk

Adverse event: Rib fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 14 affected / 527 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 42 affected / 527 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 43 affected / 527 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 32 affected / 527 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 527 at risk

Adverse event: Blood thyroid stimulating hormone increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 527 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 29 affected / 527 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 92 affected / 527 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 527 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 527 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 527 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 27 affected / 527 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 527 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 527 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 82 affected / 527 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 108 affected / 527 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 53 affected / 527 at risk

Adverse event: Groin pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 527 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 527 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 527 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 527 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 41 affected / 527 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 19 affected / 527 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 527 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 67 affected / 527 at risk

Adverse event: Pathological fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 527 at risk

Adverse event: Spinal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 527 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 35 affected / 527 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 527 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 31 affected / 527 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 527 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 527 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 527 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 33 affected / 527 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 30 affected / 527 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 14 affected / 527 at risk

Adverse event: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 15 affected / 527 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 19 affected / 527 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 527 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 14 affected / 527 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 14 affected / 527 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 33 affected / 527 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 527 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 527 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 527 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 527 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 527 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 527 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 527 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 527 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 25 affected / 527 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 527 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 527 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 87 affected / 527 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 84 affected / 527 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 208 at risk

Adverse event: Large intestine polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 208 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 208 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 208 at risk

Adverse event: Cholangiolitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 208 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 208 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 208 at risk

Adverse event: Tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 208 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 208 at risk

Adverse event: Bone pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 208 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 208 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 208 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 208 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 208 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 208 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 208 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 208 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 208 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 208 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 208 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 208 at risk

Adverse event: Pulmonary mass
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 208 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 208 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 208 at risk

Adverse event: Venous stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 208 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 208 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 208 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 208 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 208 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 208 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 208 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 208 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 208 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 208 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 208 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 208 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 208 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 208 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 208 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 15 affected / 208 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 208 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 4 affected / 208 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 208 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 208 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 208 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 208 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 208 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 208 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 208 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 208 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 208 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 208 at risk

Adverse event: Rib fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 208 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 208 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 208 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 208 at risk

Adverse event: Blood thyroid stimulating hormone increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 208 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 208 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 208 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 208 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 208 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 208 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 208 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 208 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 208 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 208 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 208 at risk

Adverse event: Groin pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 208 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 208 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 208 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 208 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 208 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 208 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 208 at risk

Adverse event: Spinal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 208 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 208 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 208 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 208 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 208 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 208 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 208 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 208 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 208 at risk

Adverse event: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 208 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 208 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 208 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 208 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 208 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 208 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 208 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 208 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 208 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 208 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 208 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 208 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 208 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 208 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 208 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 208 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 208 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 524 at risk

Adverse event: Coagulopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 524 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 524 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 524 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 524 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 524 at risk

Adverse event: Aortic valve disease mixed
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 524 at risk

Adverse event: Arteriosclerosis coronary artery
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 524 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 524 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 524 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 524 at risk

Adverse event: Cardiac failure chronic
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 524 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 524 at risk

Adverse event: Cor pulmonale chronic
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 524 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 524 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 524 at risk

Adverse event: Mitral valve disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 524 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 524 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 524 at risk

Adverse event: Sinoatrial block
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 524 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 524 at risk

Adverse event: Supraventricular extrasystoles
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 524 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 524 at risk

Adverse event: Vertigo positional
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 524 at risk

Adverse event: Goitre
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 524 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 524 at risk

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 524 at risk

Adverse event: Abdominal pain lower
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 524 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 524 at risk

Adverse event: Gastric ulcer perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 524 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 524 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 524 at risk

Adverse event: Haemorrhagic erosive gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 524 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 524 at risk

Adverse event: Large intestinal ulcer perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 524 at risk

Adverse event: Large intestine polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 524 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 524 at risk

Adverse event: Proctalgia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 524 at risk

Adverse event: Terminal ileitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 524 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 524 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 524 at risk

Adverse event: Gait disturbance
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 524 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 524 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 524 at risk

Adverse event: Performance status decreased
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 524 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 524 at risk

Adverse event: Cholangitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 524 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 524 at risk

Adverse event: Hepatic cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 524 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 524 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 524 at risk

Adverse event: Cholecystitis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 524 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 524 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 524 at risk

Adverse event: Muscle abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 524 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 524 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 524 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 524 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 524 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 524 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 524 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 524 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 524 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 524 at risk

Adverse event: Clavicle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 524 at risk

Adverse event: Comminuted fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 524 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 524 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 524 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 524 at risk

Adverse event: Forearm fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 524 at risk

Adverse event: Hand fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 524 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 524 at risk

Adverse event: Ligament sprain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 524 at risk

Adverse event: Patella fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 524 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 524 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 524 at risk

Adverse event: Subarachnoid haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 524 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 524 at risk

Adverse event: Thoracic vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 524 at risk

Adverse event: Traumatic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 524 at risk

Adverse event: International normalised ratio increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 524 at risk

Adverse event: Weight decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 524 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 524 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 524 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 524 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 524 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 524 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 524 at risk

Adverse event: Arthropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 524 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 524 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 524 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 524 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 524 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 524 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 524 at risk

Adverse event: Pathological fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 524 at risk

Adverse event: Rheumatoid arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 524 at risk

Adverse event: Adenocarcinoma of colon
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 524 at risk

Adverse event: Adrenal neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 524 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 524 at risk

Adverse event: Burkitt's lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 524 at risk

Adverse event: Gastric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 524 at risk

Adverse event: Leiomyosarcoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 524 at risk

Adverse event: Lung carcinoma cell type unspecified stage I
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 524 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 524 at risk

Adverse event: Respiratory papilloma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 524 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 524 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 524 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 524 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 524 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 524 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 524 at risk

Adverse event: IIIrd nerve paresis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 524 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 524 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 524 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 524 at risk

Adverse event: Spinal cord compression
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 524 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 524 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 524 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 524 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 524 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 524 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 524 at risk

Adverse event: Dysuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 524 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 10 affected / 524 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 524 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 524 at risk

Adverse event: Ureteric obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 524 at risk

Adverse event: Urinary bladder haematoma
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 524 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 524 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 524 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 524 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 524 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 524 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 524 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 524 at risk

Adverse event: Hydrothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 524 at risk

Adverse event: Organising pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 524 at risk

Adverse event: Paranasal cyst
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 524 at risk

Adverse event: Pneumothorax spontaneous
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 524 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 524 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 524 at risk

Adverse event: Pulmonary mass
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 524 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 524 at risk

Adverse event: Drug eruption
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 524 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 524 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 524 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 524 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 68 affected / 524 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 29 affected / 524 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 524 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 524 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 23 affected / 524 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 524 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 524 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 58 affected / 524 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 56 affected / 524 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 524 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 41 affected / 524 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 524 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 524 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 40 affected / 524 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 107 affected / 524 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 16 affected / 524 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 32 affected / 524 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 15 affected / 524 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 524 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 524 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 524 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 524 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 44 affected / 524 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 524 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 40 affected / 524 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 524 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 524 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 47 affected / 524 at risk

Adverse event: Rib fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 14 affected / 524 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 25 affected / 524 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 18 affected / 524 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Frequency: 18 affected / 524 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 524 at risk

Adverse event: Blood thyroid stimulating hormone increased
Serious: no
Organ System: Investigations
Frequency: 16 affected / 524 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 43 affected / 524 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 55 affected / 524 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 32 affected / 524 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 34 affected / 524 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 524 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 47 affected / 524 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 22 affected / 524 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 524 at risk

Adverse event: Vitamin D deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 524 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 101 affected / 524 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 106 affected / 524 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 39 affected / 524 at risk

Adverse event: Groin pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 524 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 524 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 18 affected / 524 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 21 affected / 524 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 39 affected / 524 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 524 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 524 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 69 affected / 524 at risk

Adverse event: Pathological fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 524 at risk

Adverse event: Spinal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 524 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 24 affected / 524 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 524 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 44 affected / 524 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 524 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 524 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 524 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 28 affected / 524 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 35 affected / 524 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 21 affected / 524 at risk

Adverse event: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 16 affected / 524 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 21 affected / 524 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 14 affected / 524 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 13 affected / 524 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 10 affected / 524 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 40 affected / 524 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 524 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 524 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 524 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 524 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 524 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 524 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 524 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 524 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 58 affected / 524 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 106 affected / 524 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 524 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 121 affected / 524 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 100 affected / 524 at risk