Study: NCT01263717

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: exacerbation of existing congestive heart failure
Frequency: 1 affected / 28 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: pneumonia requiring hospitalization
Frequency: 1 affected / 28 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: diagnoses of basal cell carcinoma in 2 patients, both of whom had history of basal cell carcinoma in past
Frequency: 1 affected / 28 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 28 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 28 at risk

Adverse event: erythema at injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 28 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: arthralgia
Frequency: 4 affected / 28 at risk

Adverse event: stinging of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: stinging at injection site
Frequency: 3 affected / 28 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: myalgia
Frequency: 3 affected / 28 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 28 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 28 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 28 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: diagnoses of basal cell carcinoma in 2 patients, both of whom had history of basal cell carcinoma in past
Frequency: 1 affected / 22 at risk

Adverse event: esophageal myotomy
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Planned Heller myotomy requiring post-procedure hospitalization
Frequency: 1 affected / 22 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Notes: acute cerebrovascular accident
Frequency: 1 affected / 22 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 22 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 22 at risk

Adverse event: erythema at injection site
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: arthralgia
Frequency: 4 affected / 22 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 22 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 22 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 22 at risk