Study: NCT01976663

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 13 affected / 123 at risk

Adverse event: Injection site mass
Serious: no
Organ System: General disorders
Frequency: 9 affected / 123 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 9 affected / 123 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 5 affected / 123 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 11 affected / 123 at risk

Adverse event: Injection site mass
Serious: no
Organ System: General disorders
Frequency: 9 affected / 123 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 9 affected / 123 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 1 affected / 123 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Subject 10003-3015; occurred 1 year after treatment; assessed as unrelated to treatment
Frequency: 1 affected / 123 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Notes: Assessed as unrelated to treatment
Frequency: 1 affected / 123 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Subject 10003-3015; occurred 1 year after treatment; assessed as unrelated to treatment
Frequency: 1 affected / 123 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Assessed as unrelated to treatment
Frequency: 1 affected / 123 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Assessed as unrelated to treatment
Frequency: 1 affected / 123 at risk

Adverse event: Brain hypoxia
Serious: yes
Organ System: Nervous system disorders
Notes: Subject 10003-3015; occurred 1 year after treatment; assessed as unrelated to treatment
Frequency: 1 affected / 123 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: Subject 10003-3015; occurred 1 year after treatment; assessed as unrelated to treatment
Frequency: 1 affected / 123 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Subject 10003-3015; occurred 1 year after treatment; assessed as unrelated to treatment
Frequency: 1 affected / 123 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Subject 10003-3015; occurred 1 year after treatment; assessed as unrelated to treatment
Frequency: 1 affected / 123 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Assessed as unrelated to treatment
Frequency: 1 affected / 123 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 10 affected / 93 at risk

Adverse event: Injection site mass
Serious: no
Organ System: General disorders
Frequency: 9 affected / 93 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 3 affected / 93 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 5 affected / 93 at risk