Study: NCT00500266

Adverse event: Bradyarrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Tachyarrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1049 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1049 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1049 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Skin burning sensation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Redness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness (any) = present at site of vaccination.
Frequency: 95 affected / 666 at risk

Adverse event: Redness (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness (mild) = 2.5 to 5.0 cm
Frequency: 83 affected / 660 at risk

Adverse event: Redness (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness (moderate) = 5.1 to 10.0 cm
Frequency: 42 affected / 649 at risk

Adverse event: Redness (severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness (severe) = \>10.0 cm
Frequency: 7 affected / 638 at risk

Adverse event: Swelling (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Swelling (any) = present at site of vaccination
Frequency: 85 affected / 664 at risk

Adverse event: Swelling (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Swelling (mild) = 2.5 to 5.0 cm
Frequency: 72 affected / 658 at risk

Adverse event: Swelling (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Swelling (moderate) = 5.1 to 10.0 cm
Frequency: 36 affected / 651 at risk

Adverse event: Swelling (severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Swelling (severe) = 10.0 cm
Frequency: 4 affected / 636 at risk

Adverse event: Pain (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain (any) = present at site of vaccination.
Frequency: 396 affected / 777 at risk

Adverse event: Pain (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain (mild) = no interference with activity.
Frequency: 380 affected / 770 at risk

Adverse event: Pain (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain (moderate) = some interference with activity.
Frequency: 59 affected / 656 at risk

Adverse event: Pain (severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain (severe) = prevents routine daily activity.
Frequency: 1 affected / 634 at risk

Adverse event: Limitation of arm movement (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Limitation of arm movement (any) = present due to vaccination.
Frequency: 110 affected / 679 at risk

Adverse event: Limitation of arm movement (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Limitation of arm movement (mild) = some limitation of arm movement.
Frequency: 100 affected / 674 at risk

Adverse event: Limitation of arm movement (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Limitation of arm movement (moderate) = unable to move arm above head but able to move arm above shoulder.
Frequency: 10 affected / 636 at risk

Adverse event: Limitation of arm movement (severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Limitation of arm movement (severe) = unable to move arm above shoulder.
Frequency: 10 affected / 640 at risk

Adverse event: Fever (any)
Serious: no
Organ System: General disorders
Notes: Fever (any) = ≥38 degrees C
Frequency: 13 affected / 641 at risk

Adverse event: Fever (mild)
Serious: no
Organ System: General disorders
Notes: Fever (mild) = ≥38 degrees C but \<38.5 degrees C
Frequency: 5 affected / 636 at risk

Adverse event: Fever (severe)
Serious: no
Organ System: General disorders
Notes: Fever (severe) = ≥39 degrees C but ≤40 degrees C
Frequency: 2 affected / 635 at risk

Adverse event: Fever (potentially life threatening)
Serious: no
Organ System: General disorders
Notes: Fever (potentially life threatening) = \>40 degrees C
Frequency: 6 affected / 638 at risk

Adverse event: Fatigue (any)
Serious: no
Organ System: General disorders
Notes: Fatigue (any) = fatigue present
Frequency: 252 affected / 733 at risk

Adverse event: Fatigue (mild)
Serious: no
Organ System: General disorders
Notes: Fatigue (mild) = no interference with activity.
Frequency: 204 affected / 710 at risk

Adverse event: Fatigue (moderate)
Serious: no
Organ System: General disorders
Notes: Fatigue (moderate) = some interference with activity.
Frequency: 104 affected / 683 at risk

Adverse event: Fatigue (severe)
Serious: no
Organ System: General disorders
Notes: Fatigue (severe) = prevents routine daily activity.
Frequency: 13 affected / 639 at risk

Adverse event: Headache (any)
Serious: no
Organ System: General disorders
Notes: Headache (any) = headache present.
Frequency: 183 affected / 702 at risk

Adverse event: Headache (mild)
Serious: no
Organ System: General disorders
Notes: Headache (mild) = no interference with activity.
Frequency: 168 affected / 696 at risk

Adverse event: Headache (moderate)
Serious: no
Organ System: General disorders
Notes: Headache (moderate) = some interference with activity.
Frequency: 59 affected / 655 at risk

Adverse event: Headache (severe)
Serious: no
Organ System: General disorders
Notes: Headache (severe) = prevents routine daily activity.
Frequency: 5 affected / 637 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 49 affected / 651 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 55 affected / 658 at risk

Adverse event: Vomiting (any)
Serious: no
Organ System: General disorders
Notes: Vomiting (any) = vomiting present.
Frequency: 6 affected / 638 at risk

Adverse event: Vomiting (mild)
Serious: no
Organ System: General disorders
Notes: Vomiting (mild) = no interference with activity or 1 to 2 times in 24 hours.
Frequency: 5 affected / 637 at risk

Adverse event: Vomiting (moderate)
Serious: no
Organ System: General disorders
Notes: Vomiting (moderate) = some interference with activity or more than 2 times in 24 hours.
Frequency: 1 affected / 635 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 75 affected / 668 at risk

Adverse event: Diarrhea (any)
Serious: no
Organ System: General disorders
Notes: Diarrhea (any) = diarrhea present.
Frequency: 99 affected / 684 at risk

Adverse event: Diarrhea (mild)
Serious: no
Organ System: General disorders
Notes: Diarrhea (mild) = 2 to 3 loose stools in 24 hours.
Frequency: 87 affected / 678 at risk

Adverse event: Diarrhea (moderate)
Serious: no
Organ System: General disorders
Notes: Diarrhea (moderate) = 4 to 5 loose stools in 24 hours.
Frequency: 22 affected / 644 at risk

Adverse event: Diarrhea (severe)
Serious: no
Organ System: General disorders
Notes: Diarrhea (severe) = 6 or more loose stools in 24 hours.
Frequency: 2 affected / 635 at risk

Adverse event: New generalized muscle pain (any)
Serious: no
Organ System: General disorders
Notes: New generalized muscle pain (any) = new generalized muscle pain present.
Frequency: 177 affected / 700 at risk

Adverse event: New generalized muscle pain (mild)
Serious: no
Organ System: General disorders
Notes: New generalized muscle pain (mild) = no interference with activity.
Frequency: 139 affected / 679 at risk

Adverse event: New generalized muscle pain (moderate)
Serious: no
Organ System: General disorders
Notes: New generalized muscle pain (moderate) = some interference with activity.
Frequency: 52 affected / 658 at risk

Adverse event: New generalized muscle pain (severe)
Serious: no
Organ System: General disorders
Notes: New generalized muscle pain (severe) = prevents routine daily activity.
Frequency: 4 affected / 636 at risk

Adverse event: Aggravated generalized muscle pain (any)
Serious: no
Organ System: General disorders
Notes: Aggravated generalized muscle pain (any) = aggravated generalized muscle pain present.
Frequency: 82 affected / 669 at risk

Adverse event: Aggravated generalized muscle pain (mild)
Serious: no
Organ System: General disorders
Notes: Aggravated generalized muscle pain (mild) = no interference with activity.
Frequency: 49 affected / 650 at risk

Adverse event: Aggravated generalized muscle pain (moderate)
Serious: no
Organ System: General disorders
Notes: Aggravated generalized muscle pain (moderate) = some interference with activity.
Frequency: 42 affected / 655 at risk

Adverse event: Aggravated generalized muscle pain (severe)
Serious: no
Organ System: General disorders
Notes: Aggravated generalized muscle pain (severe) = prevents routine daily activity.
Frequency: 9 affected / 639 at risk

Adverse event: New generalized joint pain (any)
Serious: no
Organ System: General disorders
Notes: New generalized joint pain (any) = new generalized joint pain present.
Frequency: 85 affected / 665 at risk

Adverse event: New generalized joint pain (mild)
Serious: no
Organ System: General disorders
Notes: New generalized joint pain (mild) = no interference with activity.
Frequency: 53 affected / 651 at risk

Adverse event: New generalized joint pain (moderate)
Serious: no
Organ System: General disorders
Notes: New generalized joint pain (moderate) = some interference with activity.
Frequency: 37 affected / 648 at risk

Adverse event: New generalized joint pain (severe)
Serious: no
Organ System: General disorders
Notes: New generalized joint pain (severe) = prevents routine daily activity.
Frequency: 5 affected / 637 at risk

Adverse event: Aggravated generalized joint pain (any)
Serious: no
Organ System: General disorders
Notes: Aggravated generalized joint pain (any) = aggravated generalized joint pain present.
Frequency: 64 affected / 661 at risk

Adverse event: Aggravated generalized joint pain (mild)
Serious: no
Organ System: General disorders
Notes: Aggravated generalized joint pain (mild) = no interference with activity.
Frequency: 37 affected / 647 at risk

Adverse event: Aggravated generalized joint pain (moderate)
Serious: no
Organ System: General disorders
Notes: Aggravated generalized joint pain (moderate) = some interference with activity.
Frequency: 33 affected / 647 at risk

Adverse event: Aggravated generalized joint pain (severe)
Serious: no
Organ System: General disorders
Notes: Aggravated generalized joint pain (severe) = prevents routine daily activity.
Frequency: 7 affected / 637 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Diabetic retinopathy
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 1049 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 1049 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1049 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1049 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Haemorrhoidal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Retching
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 1049 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 1049 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 1049 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 1049 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 1049 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 1049 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1049 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1049 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1049 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1049 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1049 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1049 at risk

Adverse event: Eye infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1049 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1049 at risk

Adverse event: Localised infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1049 at risk

Adverse event: Nail infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1049 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1049 at risk

Adverse event: Staphylococcal skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1049 at risk

Adverse event: Tinea cruris
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1049 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1049 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1049 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1049 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1049 at risk

Adverse event: Electric shock
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1049 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1049 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1049 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1049 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1049 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 1049 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 1049 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1049 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1049 at risk

Adverse event: Spinal osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1049 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Bursitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Musculoskeletal discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Plantar fasciitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Rotator cuff syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Benign breast neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1049 at risk

Adverse event: Endobronchial lipoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1049 at risk

Adverse event: Lung neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1049 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 1049 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 1049 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 1049 at risk

Adverse event: Carotid artery stenosis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Carpal tunnel syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Polyneuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Bipolar disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Stress
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Bladder spasm
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1049 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1049 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1049 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Pulmonary fibrosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Upper respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Actinic keratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Intertrigo
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Skin discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Skin mass
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 1049 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Bradyarrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1049 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1049 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1049 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Ischaemic cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1049 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1049 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1049 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1049 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1049 at risk

Adverse event: Enteritis infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1049 at risk

Adverse event: Lower respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1049 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1049 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1049 at risk

Adverse event: Fracture displacement
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1049 at risk

Adverse event: Postoperative renal failure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1049 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1049 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1049 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Hypovolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1049 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1049 at risk

Adverse event: Breast cancer in situ
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1049 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1049 at risk

Adverse event: Fibrosarcoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1049 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1049 at risk

Adverse event: Metastases to lymph nodes
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1049 at risk

Adverse event: Metastatic neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1049 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 / 1049 at risk

Adverse event: Ovarian cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1049 at risk

Adverse event: Renal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1049 at risk

Adverse event: Renal neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1049 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Guillain-Barre syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Hallucination
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1049 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1049 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Percutaneous coronary intervention
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1049 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1049 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1049 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1049 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1049 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1049 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 1049 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1049 at risk

Adverse event: Spinal osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1049 at risk

Adverse event: Bursitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 1049 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1049 at risk

Adverse event: Rotator cuff syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Carpal tunnel syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 1049 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1049 at risk

Adverse event: Pulmonary fibrosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1049 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 1049 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Angina unstable
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Aortic valve incompetence
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Arteriosclerosis coronary artery
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Left ventricular hypertrophy
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Tricuspid valve incompetence
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Deafness neurosensory
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 1049 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1049 at risk

Adverse event: Diverticulum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1049 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1049 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Suprapubic pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1049 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1049 at risk

Adverse event: Craniofacial fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1049 at risk

Adverse event: Incisional hernia
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1049 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1049 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1049 at risk

Adverse event: Blood thyroid stimulating hormone increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1049 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1049 at risk

Adverse event: Glucose tolerance impaired
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Type 2 diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Osteopenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1049 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1049 at risk

Adverse event: Joint range of motion decreased
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Lumbar spinal stenosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Sacroiliitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Meningioma benign
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1049 at risk

Adverse event: Narcolepsy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Restless legs syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Hypertonic bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Renal mass
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Atrophic vulvovaginitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Benign prostatic hyperplasia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1049 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Emphysema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1049 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Milia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Joint prosthesis user
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 1049 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Peripheral vascular disorder
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1049 at risk

Adverse event: Giant cell arteritis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1049 at risk