Study: NCT00051363

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 556 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 556 at risk

Adverse event: Dermatological
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 556 at risk

Adverse event: General
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 556 at risk

Adverse event: GI / Digestive
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal / Digestive
Frequency: 6 affected / 556 at risk

Adverse event: HEENT
Serious: yes
Organ System: General disorders
Notes: Head, eyes, ears, nose, and throat
Frequency: 1 affected / 556 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 556 at risk

Adverse event: Neurological
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 556 at risk

Adverse event: Other accident
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 556 at risk

Adverse event: Psychiatric
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 556 at risk

Adverse event: Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 556 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 27 affected / 556 at risk

Adverse event: Motor Vehicle Accident (MVA)
Serious: no
Organ System: General disorders
Frequency: 10 affected / 556 at risk

Adverse event: Dermatological
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 101 affected / 556 at risk

Adverse event: Endocrinological
Serious: no
Organ System: Endocrine disorders
Frequency: 7 affected / 556 at risk

Adverse event: General
Serious: no
Organ System: General disorders
Frequency: 52 affected / 556 at risk

Adverse event: Genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 13 affected / 556 at risk

Adverse event: GI / Digestive
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal / Digestive
Frequency: 32 affected / 556 at risk

Adverse event: HEENT
Serious: no
Organ System: General disorders
Notes: Head, eyes, ears, nose, and throat
Frequency: 207 affected / 556 at risk

Adverse event: Hematologic / Lymphatic
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 556 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 44 affected / 556 at risk

Adverse event: Near-miss MVA
Serious: no
Organ System: General disorders
Notes: Near-miss Motor Vehicle Accident
Frequency: 7 affected / 556 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 33 affected / 556 at risk

Adverse event: Psychiatric
Serious: no
Organ System: Psychiatric disorders
Frequency: 42 affected / 556 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 135 affected / 556 at risk

Adverse event: Other Accident
Serious: no
Organ System: General disorders
Frequency: 20 affected / 556 at risk

Adverse event: Work-related Accident
Serious: no
Organ System: General disorders
Frequency: 4 affected / 556 at risk

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 542 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 542 at risk

Adverse event: General
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 542 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 542 at risk

Adverse event: GI / Digestive
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal / Digestive
Frequency: 5 affected / 542 at risk

Adverse event: HEENT
Serious: yes
Organ System: General disorders
Notes: Head, eyes, ears, nose, and throat
Frequency: 1 affected / 542 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 542 at risk

Adverse event: Near-miss MVA
Serious: yes
Organ System: General disorders
Notes: Near-miss Motor Vehicle Accident
Frequency: 3 affected / 542 at risk

Adverse event: Other accident
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 542 at risk

Adverse event: Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 542 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 23 affected / 542 at risk

Adverse event: Motor Vehicle Accident (MVA)
Serious: no
Organ System: General disorders
Frequency: 11 affected / 542 at risk

Adverse event: Dermatological
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 61 affected / 542 at risk

Adverse event: Endocrinological
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 542 at risk

Adverse event: General
Serious: no
Organ System: General disorders
Frequency: 36 affected / 542 at risk

Adverse event: Genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 14 affected / 542 at risk

Adverse event: GI / Digestive
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal / Digestive
Frequency: 28 affected / 542 at risk

Adverse event: HEENT
Serious: no
Organ System: General disorders
Notes: Head, eyes, ears, nose, and throat
Frequency: 154 affected / 542 at risk

Adverse event: Hematologic / Lymphatic
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 542 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 45 affected / 542 at risk

Adverse event: Near-miss MVA
Serious: no
Organ System: General disorders
Notes: Near-miss Motor Vehicle Accident
Frequency: 8 affected / 542 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 32 affected / 542 at risk

Adverse event: Psychiatric
Serious: no
Organ System: Psychiatric disorders
Frequency: 59 affected / 542 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 153 affected / 542 at risk

Adverse event: Other Accident
Serious: no
Organ System: General disorders
Frequency: 25 affected / 542 at risk

Adverse event: Work-related Accident
Serious: no
Organ System: General disorders
Frequency: 1 affected / 542 at risk