Study: NCT00854828

Adverse event: Surveillance, Epidemiology and End Results (SEER) Cancers
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: All Surveillance, Epidemiology and End Results (SEER) cancers occurring during the study were considered an SAE
Frequency: 5 affected / 171 at risk

Adverse event: Cardiac Events
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac events that met NIAMS SAE criteria
Frequency: 4 affected / 171 at risk

Adverse event: Gastrointestinal Events
Serious: yes
Organ System: Gastrointestinal disorders
Notes: GI events that met NIAMS SAE definitions
Frequency: 7 affected / 171 at risk

Adverse event: Genitourinary Event
Serious: yes
Organ System: Renal and urinary disorders
Notes: Genitourinary events meeting NIAMS SAE reporting criteria
Frequency: 3 affected / 171 at risk

Adverse event: Pulmonary Event
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pulmonary related events meeting NIAMS SAE reporting guidelines
Frequency: 14 affected / 171 at risk

Adverse event: Surgeries Unrelated to Adult Symptomatic Lumbar Scoliosis
Serious: yes
Organ System: General disorders
Notes: Surgical events NOT related to adult scoliosis resulting new hospitalization
Frequency: 32 affected / 171 at risk

Adverse event: Miscellaneous SAE
Serious: yes
Organ System: General disorders
Notes: Misc events meeting NIAMS SAE criteria. Examples: Accidental injury, Dehydration, Altered metal status, Panic Attack, C spine stenosis, septic arthritis, anaphylactic shock, Addison's disease
Frequency: 15 affected / 171 at risk

Adverse event: Adult Lumbar Scoliosis Events
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Adult Scoliosis events meeting NIAMS SAE criteria. Examples: Lumbar stenosis, revision scoliosis spine surgeries)
Frequency: 32 affected / 171 at risk

Adverse event: Circulatory Disorders
Serious: yes
Organ System: Vascular disorders
Notes: Circulatory Events meeting NIAMS SAE criteria such as transient ischemic attack, cerebrovascular accident, Deep Vein Thrombosis, Pulmonary Embolism)
Frequency: 5 affected / 171 at risk

Adverse event: Musculoskeletal Event (excluding spine related symptoms)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 65 affected / 171 at risk

Adverse event: Medication Reaction
Serious: no
Organ System: General disorders
Frequency: 8 affected / 171 at risk

Adverse event: Endocrine System Events
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 171 at risk

Adverse event: Gastrointestinal Event
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 171 at risk

Adverse event: Genitourinary Events
Serious: no
Organ System: Renal and urinary disorders
Frequency: 8 affected / 171 at risk

Adverse event: Cardiac events
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 171 at risk

Adverse event: Circulatory Events
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 171 at risk

Adverse event: Hypertensive events
Serious: no
Organ System: General disorders
Frequency: 9 affected / 171 at risk

Adverse event: Non SEER cancer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Basal and squamous cell skin cancers
Frequency: 4 affected / 171 at risk

Adverse event: Respiratory Events
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 171 at risk

Adverse event: Infectious Event (non spine)
Serious: no
Organ System: Infections and infestations
Notes: Ear, sinus, lyme disease, infected bites, herpes, etc.
Frequency: 7 affected / 171 at risk

Adverse event: Psychosocial Events
Serious: no
Organ System: Social circumstances
Frequency: 19 affected / 171 at risk

Adverse event: Reproductive
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 171 at risk

Adverse event: Vision Events
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 171 at risk

Adverse event: Misc events
Serious: no
Organ System: General disorders
Notes: Shingles, Low B12, tinnitus, syncope, restless leg syndrome, cat bite, neuropathies d/t chemo, etc.
Frequency: 13 affected / 171 at risk

Adverse event: Cerebrospinal fluid leak (intra-op)
Serious: no
Organ System: Surgical and medical procedures
Frequency: 13 affected / 171 at risk

Adverse event: Excessive blood loss/Intraop Coagulopathy
Serious: no
Organ System: Surgical and medical procedures
Frequency: 8 affected / 171 at risk

Adverse event: Ineffective fixation/Posterior element fracture
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 171 at risk

Adverse event: Spinal implant failure (no revision)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Spinal implant failure (rod fracture, hook/screw pull out, etc) that did not require revision surgery prior to end of funding. Those failures that were revised were considered SAE and reported under SAEs
Frequency: 19 affected / 171 at risk

Adverse event: Proximal junctional kyphosis/breakdown (No revision required)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Proximal breakdown that required revision surgery during funding is considered an SAE and reported as SAE.
Frequency: 9 affected / 171 at risk

Adverse event: Spine wound problems (Not requiring admission)
Serious: no
Organ System: Infections and infestations
Notes: Superficial and deep wound infections that did not require a hospitalization. If hospitalization was required, it was considered an SAE and is reported under SAEs
Frequency: 3 affected / 171 at risk

Adverse event: Surveillance, Epidemiology and End Results (SEER) Cancers
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: All Surveillance, Epidemiology and End Results (SEER) cancers occurring during the study were considered an SAE
Frequency: 11 affected / 150 at risk

Adverse event: Cardiac Events
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac events that met NIAMS SAE criteria
Frequency: 5 affected / 150 at risk

Adverse event: Gastrointestinal Events
Serious: yes
Organ System: Gastrointestinal disorders
Notes: GI events that met NIAMS SAE definitions
Frequency: 10 affected / 150 at risk

Adverse event: Genitourinary Event
Serious: yes
Organ System: Renal and urinary disorders
Notes: Genitourinary events meeting NIAMS SAE reporting criteria
Frequency: 2 affected / 150 at risk

Adverse event: Pulmonary Event
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pulmonary related events meeting NIAMS SAE reporting guidelines
Frequency: 3 affected / 150 at risk

Adverse event: Surgeries Unrelated to Adult Symptomatic Lumbar Scoliosis
Serious: yes
Organ System: General disorders
Notes: Surgical events NOT related to adult scoliosis resulting new hospitalization
Frequency: 25 affected / 150 at risk

Adverse event: Miscellaneous SAE
Serious: yes
Organ System: General disorders
Notes: Misc events meeting NIAMS SAE criteria. Examples: Accidental injury, Dehydration, Altered metal status, Panic Attack, C spine stenosis, septic arthritis, anaphylactic shock, Addison's disease
Frequency: 4 affected / 150 at risk

Adverse event: Adult Lumbar Scoliosis Events
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Adult Scoliosis events meeting NIAMS SAE criteria. Examples: Lumbar stenosis, revision scoliosis spine surgeries)
Frequency: 1 affected / 150 at risk

Adverse event: Circulatory Disorders
Serious: yes
Organ System: Vascular disorders
Notes: Circulatory Events meeting NIAMS SAE criteria such as transient ischemic attack, cerebrovascular accident, Deep Vein Thrombosis, Pulmonary Embolism)
Frequency: 5 affected / 150 at risk

Adverse event: Musculoskeletal Event (excluding spine related symptoms)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 43 affected / 150 at risk

Adverse event: Medication Reaction
Serious: no
Organ System: General disorders
Frequency: 6 affected / 150 at risk

Adverse event: Endocrine System Events
Serious: no
Organ System: Endocrine disorders
Frequency: 6 affected / 150 at risk

Adverse event: Gastrointestinal Event
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 150 at risk

Adverse event: Genitourinary Events
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 150 at risk

Adverse event: Cardiac events
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 150 at risk

Adverse event: Circulatory Events
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 150 at risk

Adverse event: Hypertensive events
Serious: no
Organ System: General disorders
Frequency: 3 affected / 150 at risk

Adverse event: Non SEER cancer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Basal and squamous cell skin cancers
Frequency: 4 affected / 150 at risk

Adverse event: Respiratory Events
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 150 at risk

Adverse event: Infectious Event (non spine)
Serious: no
Organ System: Infections and infestations
Notes: Ear, sinus, lyme disease, infected bites, herpes, etc.
Frequency: 8 affected / 150 at risk

Adverse event: Psychosocial Events
Serious: no
Organ System: Social circumstances
Frequency: 11 affected / 150 at risk

Adverse event: Reproductive
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 150 at risk

Adverse event: Vision Events
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 150 at risk

Adverse event: Misc events
Serious: no
Organ System: General disorders
Notes: Shingles, Low B12, tinnitus, syncope, restless leg syndrome, cat bite, neuropathies d/t chemo, etc.
Frequency: 11 affected / 150 at risk