Study: NCT03285477

Adverse event: Aortic valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 176 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 176 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 176 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 176 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 176 at risk

Adverse event: Iritis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 176 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 176 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 176 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 176 at risk

Adverse event: Faeces discoloured
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 176 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 176 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 176 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 176 at risk

Adverse event: Application site paraesthesia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 176 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 8 affected / 176 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 176 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 176 at risk

Adverse event: Allergy to arthropod sting
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 176 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 176 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 176 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 176 at risk

Adverse event: Labyrinthitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 176 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 176 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 176 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 176 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 176 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 176 at risk

Adverse event: Wound infection staphylococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 176 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 176 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 176 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 176 at risk

Adverse event: Post procedural complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 176 at risk

Adverse event: Rib fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 176 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 176 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 176 at risk

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 176 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 1 affected / 176 at risk

Adverse event: Heart rate increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 176 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 176 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 176 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 176 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 176 at risk

Adverse event: Chest wall mass
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 176 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 176 at risk

Adverse event: Basal cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 176 at risk

Adverse event: Prostate cancer
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 176 at risk

Adverse event: Squamous cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 176 at risk

Adverse event: Squamous cell carcinoma of head and neck
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 176 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 176 at risk

Adverse event: Essential tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 176 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 176 at risk

Adverse event: Parkinson's disease
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 176 at risk

Adverse event: Glycosuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 176 at risk

Adverse event: Benign prostatic hyperplasia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 176 at risk

Adverse event: Pulmonary mass
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 176 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 176 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 176 at risk

Adverse event: Actinic keratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 176 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 176 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 176 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 176 at risk

Adverse event: Tooth extraction
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 176 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 176 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 176 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 175 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 175 at risk

Adverse event: Hairy cell leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 175 at risk

Adverse event: Nodal rhythm
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 175 at risk

Adverse event: Benign familial pemphigus
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 175 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 175 at risk

Adverse event: Blepharospasm
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 175 at risk

Adverse event: Inguinal hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 175 at risk

Adverse event: Hyperaesthesia teeth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 175 at risk

Adverse event: Application site discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Application site dryness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 11 affected / 175 at risk

Adverse event: Application site paraesthesia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 175 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 13 affected / 175 at risk

Adverse event: Application site warmth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Cyst
Serious: no
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 175 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 175 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 175 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 175 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 175 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 175 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 175 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 175 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 175 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 175 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 175 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 175 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 175 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 175 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 175 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 175 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 175 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 175 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 175 at risk

Adverse event: Spinal column injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 175 at risk

Adverse event: Sunburn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 175 at risk

Adverse event: Wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 175 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 175 at risk

Adverse event: Blood potassium increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 175 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Investigations
Frequency: 1 affected / 175 at risk

Adverse event: Glucose urine present
Serious: no
Organ System: Investigations
Frequency: 2 affected / 175 at risk

Adverse event: Heart rate irregular
Serious: no
Organ System: Investigations
Frequency: 1 affected / 175 at risk

Adverse event: Protein urine
Serious: no
Organ System: Investigations
Frequency: 1 affected / 175 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 175 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 175 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 175 at risk

Adverse event: Basal cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 175 at risk

Adverse event: Bowen's disease
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 175 at risk

Adverse event: Malignant melanoma stage 0
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 175 at risk

Adverse event: Seborrhoeic keratosis
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 175 at risk

Adverse event: Squamous cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 175 at risk

Adverse event: Squamous cell carcinoma of head and neck
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 175 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 175 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 175 at risk

Adverse event: Glycosuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 175 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 175 at risk

Adverse event: Prostatitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 175 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 175 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 175 at risk

Adverse event: Actinic keratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 175 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 175 at risk

Adverse event: Papule
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 175 at risk

Adverse event: Skin odour abnormal
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 175 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 175 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 175 at risk