Study: NCT02253147

Adverse event: Arthralgia
Serious: yes
Organ System: General disorders
Notes: unrelated to the study device
Frequency: 1 affected / 120 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: General disorders
Notes: unrelated to the study device
Frequency: 1 affected / 120 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: unrelated to the study device
Frequency: 1 affected / 120 at risk

Adverse event: Injection Lumps/Bumps
Serious: no
Organ System: General disorders
Frequency: 45 affected / 120 at risk

Adverse event: Injection site firmness
Serious: no
Organ System: General disorders
Frequency: 45 affected / 120 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 24 affected / 120 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Frequency: 19 affected / 120 at risk

Adverse event: Injection site discolouration
Serious: no
Organ System: General disorders
Frequency: 13 affected / 120 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 8 affected / 120 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 8 affected / 120 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 120 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 120 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 120 at risk

Adverse event: Telangiectasia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 120 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: General disorders
Notes: unrelated to the study device
Frequency: 1 affected / 120 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: General disorders
Notes: unrelated to the study device
Frequency: 1 affected / 120 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: unrelated to the study device
Frequency: 1 affected / 120 at risk

Adverse event: Injection Lumps/Bumps
Serious: no
Organ System: General disorders
Frequency: 34 affected / 120 at risk

Adverse event: Injection site firmness
Serious: no
Organ System: General disorders
Frequency: 34 affected / 120 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 17 affected / 120 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Frequency: 12 affected / 120 at risk

Adverse event: Injection site discolouration
Serious: no
Organ System: General disorders
Frequency: 7 affected / 120 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 8 affected / 120 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 4 affected / 120 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 120 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 120 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 120 at risk

Adverse event: Telangiectasia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 120 at risk