Study: NCT00291018

Adverse event: Pain - Back and Lower Extremities
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 103 at risk

Adverse event: Pain - Shoulder
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 103 at risk

Adverse event: Surgery - Index Level
Serious: yes
Organ System: Surgical and medical procedures
Notes: Surgery at the original index level of the cervical spine
Frequency: 2 affected / 103 at risk

Adverse event: Surgery - Other
Serious: yes
Organ System: Surgical and medical procedures
Notes: Surgery not at the index (cervical level)
Frequency: 21 affected / 103 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 103 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 103 at risk

Adverse event: Pain - Back
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 103 at risk

Adverse event: Pain - Neck and Upper Extremities
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 103 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 103 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 103 at risk

Adverse event: Pain - Neck
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 103 at risk

Adverse event: Pain - Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 103 at risk

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 103 at risk

Adverse event: Pain - Neck
Serious: no
Organ System: Nervous system disorders
Frequency: 35 affected / 103 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 34 affected / 103 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 103 at risk

Adverse event: Pain - Back
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 103 at risk

Adverse event: Surgery - Other
Serious: no
Organ System: Surgical and medical procedures
Notes: Surgery not at the index (cervical) level
Frequency: 23 affected / 103 at risk

Adverse event: Pain - Shoulder
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 103 at risk

Adverse event: Pain - Upper Extremities
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 103 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 103 at risk

Adverse event: Neurological
Serious: no
Organ System: Psychiatric disorders
Frequency: 19 affected / 103 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 19 affected / 103 at risk

Adverse event: Numbness Non-Index Level Related
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 103 at risk

Adverse event: Pain - Back and Lower Extremities
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 103 at risk

Adverse event: Pain - Other
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 103 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 103 at risk

Adverse event: Pain - Neck and Upper Extremities with Numbness
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 103 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 103 at risk

Adverse event: Genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 103 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 103 at risk

Adverse event: Pain - Neck and Shoulder
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 103 at risk

Adverse event: Pain - Neck and Upper Extremities
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 103 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 103 at risk

Adverse event: Infection - Other Non-Wound Related
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 103 at risk

Adverse event: Pain - Upper Extremities with Numbness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 103 at risk

Adverse event: Musculoskeletal Spasms - Neck
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 103 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 103 at risk

Adverse event: Surgery - Index Level
Serious: no
Organ System: Surgical and medical procedures
Notes: Surgery at the index level (cervical)
Frequency: 2 affected / 103 at risk

Adverse event: Pain - Back and Lower Extremities
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 106 at risk

Adverse event: Pain - Shoulder
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 106 at risk

Adverse event: Surgery - Index Level
Serious: yes
Organ System: Surgical and medical procedures
Notes: Surgery at the original index level of the cervical spine
Frequency: 10 affected / 106 at risk

Adverse event: Surgery - Other
Serious: yes
Organ System: Surgical and medical procedures
Notes: Surgery not at the index (cervical level)
Frequency: 27 affected / 106 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 106 at risk

Adverse event: Pain - Back
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 106 at risk

Adverse event: Pain - Neck and Upper Extremities
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 106 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 106 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 106 at risk

Adverse event: Pain - Neck
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 106 at risk

Adverse event: Pain - Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 106 at risk

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 106 at risk

Adverse event: Pain - Neck
Serious: no
Organ System: Nervous system disorders
Frequency: 41 affected / 106 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 106 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 106 at risk

Adverse event: Pain - Back
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 106 at risk

Adverse event: Surgery - Other
Serious: no
Organ System: Surgical and medical procedures
Notes: Surgery not at the index (cervical) level
Frequency: 29 affected / 106 at risk

Adverse event: Pain - Shoulder
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 106 at risk

Adverse event: Pain - Upper Extremities
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 106 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 106 at risk

Adverse event: Neurological
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 106 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 18 affected / 106 at risk

Adverse event: Numbness Non-Index Level Related
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 106 at risk

Adverse event: Pain - Back and Lower Extremities
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 106 at risk

Adverse event: Pain - Other
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 106 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 106 at risk

Adverse event: Pain - Neck and Upper Extremities with Numbness
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 106 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 106 at risk

Adverse event: Genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 106 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 106 at risk

Adverse event: Pain - Neck and Shoulder
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 106 at risk

Adverse event: Pain - Neck and Upper Extremities
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 106 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 106 at risk

Adverse event: Infection - Other Non-Wound Related
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 106 at risk

Adverse event: Pain - Upper Extremities with Numbness
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 106 at risk

Adverse event: Musculoskeletal Spasms - Neck
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 106 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 106 at risk

Adverse event: Surgery - Index Level
Serious: no
Organ System: Surgical and medical procedures
Notes: Surgery at the index level (cervical)
Frequency: 10 affected / 106 at risk

Adverse event: Pain - Back and Lower Extremities
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 136 at risk

Adverse event: Pain - Shoulder
Serious: yes
Organ System: Nervous system disorders
Frequency: 7 affected / 136 at risk

Adverse event: Surgery - Index Level
Serious: yes
Organ System: Surgical and medical procedures
Notes: Surgery at the original index level of the cervical spine
Frequency: 1 affected / 136 at risk

Adverse event: Surgery - Other
Serious: yes
Organ System: Surgical and medical procedures
Notes: Surgery not at the index (cervical level)
Frequency: 18 affected / 136 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 136 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 136 at risk

Adverse event: Pain - Back
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 136 at risk

Adverse event: Pain - Neck and Upper Extremities
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 136 at risk

Adverse event: Genitourinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 136 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 136 at risk

Adverse event: Pain - Neck
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 136 at risk

Adverse event: Pain - Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 136 at risk

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 136 at risk

Adverse event: Pain - Neck
Serious: no
Organ System: Nervous system disorders
Frequency: 59 affected / 136 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 39 affected / 136 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 31 affected / 136 at risk

Adverse event: Pain - Back
Serious: no
Organ System: Nervous system disorders
Frequency: 32 affected / 136 at risk

Adverse event: Surgery - Other
Serious: no
Organ System: Surgical and medical procedures
Notes: Surgery not at the index (cervical) level
Frequency: 24 affected / 136 at risk

Adverse event: Pain - Shoulder
Serious: no
Organ System: Nervous system disorders
Frequency: 33 affected / 136 at risk

Adverse event: Pain - Upper Extremities
Serious: no
Organ System: Nervous system disorders
Frequency: 34 affected / 136 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 136 at risk

Adverse event: Neurological
Serious: no
Organ System: Psychiatric disorders
Frequency: 29 affected / 136 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 21 affected / 136 at risk

Adverse event: Numbness Non-Index Level Related
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 136 at risk

Adverse event: Pain - Back and Lower Extremities
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 136 at risk

Adverse event: Pain - Other
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 136 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 136 at risk

Adverse event: Pain - Neck and Upper Extremities with Numbness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 136 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 136 at risk

Adverse event: Genitourinary
Serious: no
Organ System: Renal and urinary disorders
Frequency: 11 affected / 136 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 136 at risk

Adverse event: Pain - Neck and Shoulder
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 136 at risk

Adverse event: Pain - Neck and Upper Extremities
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 136 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 136 at risk

Adverse event: Infection - Other Non-Wound Related
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 136 at risk

Adverse event: Pain - Upper Extremities with Numbness
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 136 at risk

Adverse event: Musculoskeletal Spasms - Neck
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 136 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 136 at risk

Adverse event: Surgery - Index Level
Serious: no
Organ System: Surgical and medical procedures
Notes: Surgery at the index level (cervical)
Frequency: 1 affected / 136 at risk