Study: NCT01156675

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 107 at risk

Adverse event: Cardiovascular
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 107 at risk

Adverse event: Carpal tunnel syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 107 at risk

Adverse event: Cerebrovascular
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 107 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 107 at risk

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 107 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 107 at risk

Adverse event: Other
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 107 at risk

Adverse event: Pain - Hip
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 107 at risk

Adverse event: Pain - Lower Extremities
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 107 at risk

Adverse event: Pain - Neck and/or Upper Extremities
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 107 at risk

Adverse event: Pseudoarthrosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 107 at risk

Adverse event: Surgery - Index Level
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 21 affected / 107 at risk

Adverse event: Surgery - Non-Index Lumbar
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 107 at risk

Adverse event: Surgery - Non-Index Lumbar
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 107 at risk

Adverse event: Injury
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 107 at risk

Adverse event: Urogenital
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 107 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 107 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 107 at risk

Adverse event: Dysesthesia - Lower Extremities
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 107 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 107 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 107 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 107 at risk

Adverse event: Infection - Superficial Wound
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 107 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 107 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 107 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 10 affected / 107 at risk

Adverse event: Pain - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 34 affected / 107 at risk

Adverse event: Pain - Back and Hip
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 107 at risk

Adverse event: Pain - Back and Lower Extemities
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 107 at risk

Adverse event: Pain - Hip
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 107 at risk

Adverse event: Pain - Lower Extremities
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 107 at risk

Adverse event: Pain - Lower Extremities with Dysesthesia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 107 at risk

Adverse event: Pain - Neck and/or Upper Extremities
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 107 at risk

Adverse event: Pain - Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 107 at risk

Adverse event: Paresthesia - Lower Extremities
Serious: no
Organ System: General disorders
Frequency: 11 affected / 107 at risk

Adverse event: Paresthesia - Upper Extremities
Serious: no
Organ System: General disorders
Frequency: 2 affected / 107 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 107 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 107 at risk

Adverse event: Spinous Process Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 107 at risk

Adverse event: Surgery - Index Level
Serious: no
Organ System: General disorders
Frequency: 1 affected / 107 at risk

Adverse event: Injury
Serious: no
Organ System: Social circumstances
Frequency: 6 affected / 107 at risk

Adverse event: Urogenital
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 107 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 107 at risk

Adverse event: Wound Issue
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 107 at risk

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

Adverse event: Compressive Peripheral Neuropathy (Non-CTS)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 106 at risk

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

Adverse event: Gastrointestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 106 at risk

Adverse event: Infection - Superficial Wound
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 106 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 106 at risk

Adverse event: Pain - Back
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 106 at risk

Adverse event: Pain - Hip
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 106 at risk

Adverse event: Pain - Lower Extremities
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 106 at risk

Adverse event: Pain - Neck and/or Upper Extremities
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 106 at risk

Adverse event: Surgery - Index Level
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 12 affected / 106 at risk

Adverse event: Neoplasm malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 106 at risk

Adverse event: Cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 106 at risk

Adverse event: Carpal Tunnel Syndrome (CTS)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 106 at risk

Adverse event: Dysesthesia - Lower Extremities
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 106 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 106 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 106 at risk

Adverse event: Infection - Other
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 106 at risk

Adverse event: Infection - Superficial Wound
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 106 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 106 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 106 at risk

Adverse event: Neurological
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 106 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 6 affected / 106 at risk

Adverse event: Pain - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 32 affected / 106 at risk

Adverse event: Pain - Back and Hip
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 106 at risk

Adverse event: Pain - Back and Lower Extemities
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 106 at risk

Adverse event: Pain - Hip
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 106 at risk

Adverse event: Pain - Lower Extremities
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 33 affected / 106 at risk

Adverse event: Pain - Lower Extremities with Dysesthesia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 106 at risk

Adverse event: Pain - Neck and/or Upper Extremities
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 106 at risk

Adverse event: Paresthesia - Lower Extremities
Serious: no
Organ System: General disorders
Frequency: 10 affected / 106 at risk

Adverse event: Paresthesia - Upper Extremities
Serious: no
Organ System: General disorders
Frequency: 1 affected / 106 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 106 at risk

Adverse event: Spinous Process Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 106 at risk

Adverse event: Injury
Serious: no
Organ System: Social circumstances
Frequency: 3 affected / 106 at risk

Adverse event: Urogenital
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 106 at risk

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

Adverse event: Wound Issue
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 106 at risk

Adverse event: Pain - Back and Lower Extemities with Dysesthesia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 106 at risk

Adverse event: Pain - Back
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Pain - Lower Extremities
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 2 at risk