Study: NCT01820260

Adverse event: Eyelid oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 12 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Transient ischaemic attack
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 10 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 4 affected / 10 at risk

Adverse event: Application site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Salivary gland neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 10 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 10 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Scoliosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nasal septum deviation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 12 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: Application site discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 12 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 12 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 12 at risk

Adverse event: Application site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Skin burning sensation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 10 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 10 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Parosmia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 10 at risk

Adverse event: upper airway cough syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 6 affected / 11 at risk

Adverse event: Application site paraesthesia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 11 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Application site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Periorbital oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 11 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Application site paraesthesia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 11 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 11 at risk

Adverse event: Application site reaction
Serious: no
Organ System: General disorders
Frequency: 3 affected / 11 at risk

Adverse event: Application site oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 56 affected / 62 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 18 affected / 62 at risk

Adverse event: Application site discomfort
Serious: no
Organ System: General disorders
Frequency: 2 affected / 62 at risk

Adverse event: Application site paraesthesia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 62 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 62 at risk

Adverse event: Appilcation site dryness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 62 at risk

Adverse event: Nasopharyngititis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 62 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 62 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 62 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 62 at risk

Adverse event: Eye swelling
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 62 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 62 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 62 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 2 affected / 62 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 62 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 62 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 56 affected / 64 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 10 affected / 64 at risk

Adverse event: Application site discomfort
Serious: no
Organ System: General disorders
Frequency: 3 affected / 64 at risk

Adverse event: Application site paraesthesia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 64 at risk

Adverse event: Nasopharyngititis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 64 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 64 at risk

Adverse event: Eye swelling
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 64 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 64 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 64 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 64 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 60 affected / 64 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 9 affected / 64 at risk

Adverse event: Application site discomfort
Serious: no
Organ System: General disorders
Frequency: 2 affected / 64 at risk

Adverse event: Application site paraesthesia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 64 at risk

Adverse event: Nasopharyngititis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 64 at risk

Adverse event: Eye swelling
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 64 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 64 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 1 affected / 64 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 64 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 64 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 57 affected / 61 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 9 affected / 61 at risk

Adverse event: Application site discomfort
Serious: no
Organ System: General disorders
Frequency: 3 affected / 61 at risk

Adverse event: Nasopharyngititis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 61 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 61 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 61 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 1 affected / 61 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 61 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: Appilcation site dryness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 1 affected / 31 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 31 at risk

Adverse event: Joint stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Pulmonary congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 31 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 31 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Cyst rupture
Serious: no
Organ System: General disorders
Frequency: 1 affected / 31 at risk

Adverse event: Nasopharyngititis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 31 at risk