Study: NCT00312572

Adverse event: Exacerbation of anxiety disorder
Serious: yes
Organ System: Psychiatric disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 101 at risk

Adverse event: Rash NOS, Chest, Arms, Face
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Systematic and nonsystematic assessments
Frequency: 2 affected / 101 at risk

Adverse event: Rash generalized
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 101 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 7 affected / 101 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 11 affected / 101 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 101 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 101 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 101 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 101 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 101 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 101 at risk

Adverse event: Creutzfeldt-Jacob disease - DEATH
Serious: yes
Organ System: Infections and infestations
Notes: DEATH Systematic and nonsystematic assessments
Frequency: 1 affected / 103 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 103 at risk

Adverse event: Increased hypertension
Serious: yes
Organ System: Vascular disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 103 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 103 at risk

Adverse event: Myositis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Systematic and nonsystematic assessments
Frequency: 1 affected / 103 at risk

Adverse event: Application site erythema
Serious: no
Organ System: General disorders
Frequency: 7 affected / 103 at risk

Adverse event: Application site pruritus
Serious: no
Organ System: General disorders
Frequency: 18 affected / 103 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 103 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 103 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 103 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 103 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 103 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 103 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 266 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 266 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 266 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 266 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 266 at risk