Study: NCT02547363

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 209 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 209 at risk

Adverse event: Appendicitis perforated
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 209 at risk

Adverse event: Neoplasm of appendix
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 209 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 209 at risk

Adverse event: Periorbital oedema
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 209 at risk

Adverse event: Application site discomfort
Serious: no
Organ System: General disorders
Frequency: 6 affected / 209 at risk

Adverse event: Application site injury
Serious: no
Organ System: General disorders
Frequency: 8 affected / 209 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 127 affected / 209 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 64 affected / 209 at risk

Adverse event: Application site scar
Serious: no
Organ System: General disorders
Frequency: 1 affected / 209 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 5 affected / 209 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 209 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 209 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 209 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 104 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 104 at risk

Adverse event: Application site discomfort
Serious: no
Organ System: General disorders
Frequency: 2 affected / 104 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 104 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 2 affected / 104 at risk

Adverse event: Application site scar
Serious: no
Organ System: General disorders
Frequency: 1 affected / 104 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 104 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 104 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 204 at risk

Adverse event: Application site scar
Serious: no
Organ System: General disorders
Frequency: 10 affected / 204 at risk

Adverse event: Squamous cell carcinoma of skin
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 5 affected / 204 at risk

Adverse event: Post inflammatory pigmentation change
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 204 at risk

Adverse event: Application site scar
Serious: no
Organ System: General disorders
Frequency: 7 affected / 86 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 / 86 at risk

Adverse event: Post inflammatory pigmentation change
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 86 at risk