Study: NCT00440115

Adverse event: Dystonia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 251 at risk

Adverse event: Arterial Surgery
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 251 at risk

Adverse event: Broken Neck
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 251 at risk

Adverse event: Bronchitis/COPD Exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 251 at risk

Adverse event: Collapsed lung
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: As a result of a rodeo injury
Frequency: 1 affected / 251 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 251 at risk

Adverse event: Depression and Suicidal Ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 251 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 251 at risk

Adverse event: Removal of Lung Mass
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 251 at risk

Adverse event: Respiratory fume inhalation disorder
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: As a result of occupational hazard
Frequency: 1 affected / 251 at risk

Adverse event: Ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 251 at risk

Adverse event: Heart Surgery
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 251 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 251 at risk

Adverse event: Constipation
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 251 at risk

Adverse event: Depression
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 251 at risk

Adverse event: Dizziness/Light Headedness
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 251 at risk

Adverse event: Elevated heart rate or blood pressure
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 251 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 251 at risk

Adverse event: Blood Clot
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 251 at risk

Adverse event: Bowel Falure
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 251 at risk

Adverse event: Broken Bone
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 251 at risk

Adverse event: Concussion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: As a result of a fall
Frequency: 1 affected / 251 at risk

Adverse event: Crohn's Disease Complication
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 251 at risk

Adverse event: Diabetes Complication
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 251 at risk

Adverse event: Eye injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 251 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 251 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 251 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 251 at risk

Adverse event: Strep Throat
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 251 at risk

Adverse event: Scheduled Surgery/Medical Procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 9 affected / 251 at risk

Adverse event: Irritability/Nervousness
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 251 at risk

Adverse event: Nausea
Serious: no
Organ System: Product Issues
Frequency: 5 affected / 251 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 251 at risk

Adverse event: Tremor
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 251 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Product Issues
Frequency: 15 affected / 251 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 251 at risk

Adverse event: Bronchitis/COPD Exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 249 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 249 at risk

Adverse event: Chest pain
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 249 at risk

Adverse event: Depression
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 249 at risk

Adverse event: Dizziness/Light Headedness
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 249 at risk

Adverse event: Elevated heart rate or blood pressure
Serious: no
Organ System: Product Issues
Frequency: 6 affected / 249 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Headache
Serious: no
Organ System: Product Issues
Frequency: 4 affected / 249 at risk

Adverse event: Blood Clot
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 249 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 249 at risk

Adverse event: Scheduled Surgery/Medical Procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 249 at risk

Adverse event: Irritability/Nervousness
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 249 at risk

Adverse event: Nausea
Serious: no
Organ System: Product Issues
Frequency: 7 affected / 249 at risk

Adverse event: Tremor
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 249 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Product Issues
Frequency: 8 affected / 249 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 249 at risk

Adverse event: Atrial fibriliation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 250 at risk

Adverse event: Bronchitis/COPD Exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 250 at risk

Adverse event: Chest pain
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 250 at risk

Adverse event: Dizziness/Light Headedness
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 250 at risk

Adverse event: Elevated heart rate or blood pressure
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 250 at risk

Adverse event: Broken Bone
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 250 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 250 at risk

Adverse event: Scheduled Surgery/Medical Procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 250 at risk

Adverse event: Irritability/Nervousness
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 250 at risk

Adverse event: Nausea
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 250 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Product Issues
Frequency: 7 affected / 250 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 250 at risk