Study: NCT03092219

Adverse event: Breast cancer
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: unrelated to the study device
Frequency: 1 affected / 200 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: unrelated to the study device
Frequency: 2 affected / 200 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Notes: unrelated to the study device
Frequency: 1 affected / 200 at risk

Adverse event: Pharyngeal abscess
Serious: yes
Organ System: Infections and infestations
Notes: unrelated to the study device
Frequency: 1 affected / 200 at risk

Adverse event: Intraductal proliferative breast lesion
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: unrelated to the study device
Frequency: 1 affected / 200 at risk

Adverse event: Fallopian tube cancer
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: unrelated to the study device
Frequency: 1 affected / 200 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 200 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 200 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 200 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 200 at risk

Adverse event: Lip dry
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 200 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 200 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 23 affected / 200 at risk

Adverse event: Injection site discolouration
Serious: no
Organ System: General disorders
Frequency: 14 affected / 200 at risk

Adverse event: Injection dryness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 200 at risk

Adverse event: Injection erythema
Serious: no
Organ System: General disorders
Frequency: 10 affected / 200 at risk

Adverse event: Injection site hypoaesthesia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 200 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 22 affected / 200 at risk

Adverse event: Injection site mass
Serious: no
Organ System: General disorders
Frequency: 34 affected / 200 at risk

Adverse event: Injection site movement impairment
Serious: no
Organ System: General disorders
Frequency: 3 affected / 200 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 14 affected / 200 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 6 affected / 200 at risk

Adverse event: Injection site scab
Serious: no
Organ System: General disorders
Frequency: 2 affected / 200 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 13 affected / 200 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 200 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 200 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 200 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 200 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 29 affected / 200 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 200 at risk

Adverse event: Needle track marks
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 200 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 200 at risk

Adverse event: Skin wrinkling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 200 at risk

Adverse event: Skin discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 200 at risk

Adverse event: Actinic keratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 200 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 200 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 200 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 200 at risk

Adverse event: Melanocytic naevus
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 200 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 200 at risk

Adverse event: Needle track marks
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 200 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 49 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 49 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 49 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 49 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 49 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 49 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: unrelated to the study device
Frequency: 1 affected / 151 at risk

Adverse event: Blepharitis
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 151 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 151 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Lip dry
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 151 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 151 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 14 affected / 151 at risk

Adverse event: Injection site discolouration
Serious: no
Organ System: General disorders
Frequency: 5 affected / 151 at risk

Adverse event: Injection dryness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 151 at risk

Adverse event: Injection erythema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 151 at risk

Adverse event: Injection site hypoaesthesia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 151 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 13 affected / 151 at risk

Adverse event: Injection site mass
Serious: no
Organ System: General disorders
Frequency: 25 affected / 151 at risk

Adverse event: Injection site movement impairment
Serious: no
Organ System: General disorders
Frequency: 1 affected / 151 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 10 affected / 151 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 5 affected / 151 at risk

Adverse event: Injection site scab
Serious: no
Organ System: General disorders
Frequency: 2 affected / 151 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 7 affected / 151 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 151 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 151 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 151 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 151 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 151 at risk

Adverse event: Skin wrinkling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 151 at risk

Adverse event: Skin discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 151 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: Melanocytic naevus
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 151 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 151 at risk

Adverse event: Needle track marks
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 151 at risk