Study: NCT00448448

Adverse event: Anxiety and Depression
Serious: yes
Organ System: Psychiatric disorders
Notes: Subject was hospitalized for anxiety and depression
Frequency: 1 affected / 146 at risk

Adverse event: Arm Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 146 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 30 affected / 146 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 146 at risk

Adverse event: Dislocation of patellofemoral joint
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 146 at risk

Adverse event: Eruption of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash
Frequency: 6 affected / 146 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 146 at risk

Adverse event: Fracture of great toe
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 146 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 146 at risk

Adverse event: Hip pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 146 at risk

Adverse event: Numbness of limb
Serious: no
Organ System: Nervous system disorders
Notes: Report of either or both arm and leg numbness and/or tingling
Frequency: 4 affected / 146 at risk

Adverse event: Numbness of saddle area
Serious: no
Organ System: Nervous system disorders
Notes: Report of numbness in hip area
Frequency: 1 affected / 146 at risk

Adverse event: Pain
Serious: no
Organ System: Nervous system disorders
Notes: Report of side pain
Frequency: 1 affected / 146 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 146 at risk

Adverse event: Suicidal thoughts
Serious: no
Organ System: Psychiatric disorders
Notes: Subject with history of depression; event not related to protocol
Frequency: 1 affected / 146 at risk

Adverse event: Superficial bruising
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 146 at risk

Adverse event: Superficial ulcer of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 146 at risk

Adverse event: Vaso vagal episode
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 146 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 146 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 146 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Report of asthma exacerbation
Frequency: 1 affected / 146 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 146 at risk

Adverse event: Knee reflex abnormal
Serious: no
Organ System: Nervous system disorders
Notes: Report of asymmetrical patella reflexes
Frequency: 1 affected / 146 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 146 at risk

Adverse event: SnoMed term not found
Serious: no
Organ System: Reproductive system and breast disorders
Notes: non-specific report of abnormal breast development
Frequency: 1 affected / 96 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 25 affected / 96 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 96 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 96 at risk

Adverse event: Fracture of great toe
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 96 at risk

Adverse event: Hip pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 96 at risk

Adverse event: Numbness of limb
Serious: no
Organ System: Nervous system disorders
Notes: Report of either or both arm and leg numbness and/or tingling
Frequency: 2 affected / 96 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 96 at risk