Study: NCT02979639

Adverse event: Aortic valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 401 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 401 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 401 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 401 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 401 at risk

Adverse event: Stress cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 401 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 401 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 401 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 401 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 401 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 401 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 401 at risk

Adverse event: Post procedural haematuria
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 401 at risk

Adverse event: Post procedural inflammation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 401 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 401 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 401 at risk

Adverse event: Lung adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 401 at risk

Adverse event: Myelodysplastic syndrome
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 401 at risk

Adverse event: Small intestine adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 401 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 401 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 401 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Atrial fibrilation
Serious: no
Organ System: Cardiac disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Unsolicited symptoms
Frequency: 2 affected / 401 at risk

Adverse event: Conjunctivitis allergic
Serious: no
Organ System: Eye disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Notes: Unsolicited symptoms
Frequency: 2 affected / 401 at risk

Adverse event: Keratitis
Serious: no
Organ System: Eye disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unsolicited symptoms
Frequency: 88 affected / 401 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unsolicited symptoms
Frequency: 4 affected / 401 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unsolicited symptoms
Frequency: 3 affected / 401 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Application site hyperaesthesia
Serious: no
Organ System: General disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Unsolicited symptoms
Frequency: 115 affected / 401 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Unsolicited symptoms
Frequency: 227 affected / 401 at risk

Adverse event: Feeling cold
Serious: no
Organ System: General disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Ill-defined disorder
Serious: no
Organ System: General disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Inflammation
Serious: no
Organ System: General disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Notes: Unsolicited symptoms
Frequency: 2 affected / 401 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: Unsolicited symptoms
Frequency: 125 affected / 401 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Unsolicited symptoms
Frequency: 341 affected / 401 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Notes: Unsolicited symptoms
Frequency: 8 affected / 401 at risk

Adverse event: Injection site warmth
Serious: no
Organ System: General disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Unsolicited symptoms
Frequency: 2 affected / 401 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Unsolicited symptoms
Frequency: 2 affected / 401 at risk

Adverse event: Peripheral swelling
Serious: no
Organ System: General disorders
Notes: Unsolicited symptoms
Frequency: 2 affected / 401 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Unsolicited symptoms
Frequency: 88 affected / 401 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited symptoms
Frequency: 5 affected / 401 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited symptoms
Frequency: 2 affected / 401 at risk

Adverse event: Eye infection staphilococcal
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Gastrointestinal viral infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Groin abcess
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Nasopharyngithis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited symptoms
Frequency: 10 affected / 401 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited symptoms
Frequency: 4 affected / 401 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited symptoms
Frequency: 6 affected / 401 at risk

Adverse event: Tooth abcess
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited symptoms
Frequency: 2 affected / 401 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited symptoms
Frequency: 8 affected / 401 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited symptoms
Frequency: 4 affected / 401 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: Unsolicited symptoms
Frequency: 2 affected / 401 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Arthropod sting
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unsolicited symptoms
Frequency: 2 affected / 401 at risk

Adverse event: Foot fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Injection related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Meniscus injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Procedural dizziness
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Superficial injury of eye
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Tooth fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unsolicited symptoms
Frequency: 2 affected / 401 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unsolicited symptoms
Frequency: 2 affected / 401 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unsolicited symptoms
Frequency: 5 affected / 401 at risk

Adverse event: Bursitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Joint effusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unsolicited symptoms
Frequency: 5 affected / 401 at risk

Adverse event: Muscle tightness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unsolicited symptoms
Frequency: 2 affected / 401 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unsolicited symptoms
Frequency: 2 affected / 401 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unsolicited symptoms
Frequency: 3 affected / 401 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unsolicited symptoms
Frequency: 169 affected / 401 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unsolicited symptoms
Frequency: 4 affected / 401 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unsolicited symptoms
Frequency: 2 affected / 401 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unsolicited symptoms
Frequency: 5 affected / 401 at risk

Adverse event: Spinal stenosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Basal cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Skin cancer
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Unsolicited symptoms
Frequency: 5 affected / 401 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Unsolicited symptoms
Frequency: 189 affected / 401 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Unsolicited symptoms
Frequency: 3 affected / 401 at risk

Adverse event: Lethargy
Serious: no
Organ System: Nervous system disorders
Notes: Unsolicited symptoms
Frequency: 3 affected / 401 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Unsolicited symptoms
Frequency: 2 affected / 401 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Notes: Unsolicited symptoms
Frequency: 2 affected / 401 at risk

Adverse event: Sinus headache
Serious: no
Organ System: Nervous system disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Unsolicited symptoms
Frequency: 2 affected / 401 at risk

Adverse event: Panic attack
Serious: no
Organ System: Psychiatric disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Stress
Serious: no
Organ System: Psychiatric disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Urinary tract disorder
Serious: no
Organ System: Renal and urinary disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Urine odour abnormal
Serious: no
Organ System: Renal and urinary disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unsolicited symptoms
Frequency: 10 affected / 401 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unsolicited symptoms
Frequency: 2 affected / 401 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unsolicited symptoms
Frequency: 5 affected / 401 at risk

Adverse event: Paranasal sinus hypersecretion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unsolicited symptoms
Frequency: 4 affected / 401 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unsolicited symptoms
Frequency: 2 affected / 401 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unsolicited symptoms
Frequency: 2 affected / 401 at risk

Adverse event: Sinus operation
Serious: no
Organ System: Surgical and medical procedures
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Notes: Unsolicited symptoms
Frequency: 1 affected / 401 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 78 affected / 401 at risk