Study: NCT02005666

Adverse event: Application site dryness
Serious: no
Organ System: General disorders
Frequency: 7 affected / 338 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 338 at risk

Adverse event: Application site oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 338 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 338 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 2 affected / 338 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 338 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 338 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 338 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 338 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 338 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 338 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 338 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 338 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 338 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 338 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 338 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 338 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 338 at risk

Adverse event: Chapped lips
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 338 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 338 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 338 at risk

Adverse event: Hyperchlorhydria
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 338 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 338 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 338 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 338 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 338 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 338 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 338 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 338 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 338 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 338 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 338 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 338 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 338 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 338 at risk

Adverse event: Breast tenderness
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 338 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 338 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 338 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 338 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 338 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 338 at risk

Adverse event: Eosinophil count increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 338 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 338 at risk

Adverse event: Application site dryness
Serious: no
Organ System: General disorders
Frequency: 7 affected / 343 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 343 at risk

Adverse event: Application site oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 343 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 343 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 4 affected / 343 at risk

Adverse event: Facial pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 343 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 343 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 343 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 343 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 343 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 343 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 343 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 343 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 343 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 343 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 343 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 343 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 343 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 343 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 343 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 343 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 343 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 343 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 343 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 343 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 343 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 343 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 343 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 343 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 343 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 343 at risk

Adverse event: Mechanical urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 343 at risk

Adverse event: Animal bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 343 at risk

Adverse event: Concussion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 343 at risk

Adverse event: Road traffic accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 343 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 343 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 343 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 343 at risk

Adverse event: Scleral cyst
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 343 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 343 at risk

Adverse event: Ear deformity acquired
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 343 at risk

Adverse event: Device dislocation
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 343 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 343 at risk

Adverse event: Staphylococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 343 at risk

Adverse event: Application site dryness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 169 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 169 at risk

Adverse event: Application site oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 169 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 169 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 3 affected / 169 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 169 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Gastrointestinal viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 169 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 169 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 169 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 169 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 169 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 169 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 169 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 169 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 169 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 169 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 169 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 169 at risk

Adverse event: Heat stroke
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 169 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 169 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 169 at risk