Study: NCT02838628

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 84 at risk

Adverse event: Facial paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 84 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 84 at risk

Adverse event: Atrioventricular block first degree
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 84 at risk

Adverse event: Defect conduction intraventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 84 at risk

Adverse event: Myocardial ischaemia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 84 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 84 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 84 at risk

Adverse event: Diverticulum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 84 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 6 affected / 84 at risk

Adverse event: Feeling of body temperature change
Serious: no
Organ System: General disorders
Frequency: 1 affected / 84 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 84 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 84 at risk

Adverse event: Bacteriuria
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 84 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 84 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 84 at risk

Adverse event: Overdose
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 84 at risk

Adverse event: Scratch
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 84 at risk

Adverse event: Skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 84 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 1 affected / 84 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 84 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 84 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: Meniscus injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: Squamous cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 84 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 84 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 84 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 84 at risk

Adverse event: Vertigo
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 84 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 84 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 84 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 84 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 84 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 84 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 84 at risk

Adverse event: Actinic keratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: Hair colour changes
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: Penile ulceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: Skin injury
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: Tooth extraction
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 84 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 84 at risk

Adverse event: Arteriosclerosis coronary artery
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 84 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 84 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 84 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 84 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 84 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 84 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 84 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 84 at risk

Adverse event: Clavicle fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 84 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 84 at risk

Adverse event: Rib fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 84 at risk

Adverse event: Skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 84 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 84 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: Squamous cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 84 at risk

Adverse event: Squamous cell carcinoma of skin
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 84 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 84 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: Scab
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 84 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 84 at risk