Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
NCT ID:
NCT00854828
Description:
Serious Adverse Events (SAE) were any events that resulted in:
Death Hospitalization (new or prolonged) - Exception was hospitalization for index spinal deformity correction surgery.
New disability (significant or permanent) Life threatening Unexpected but Reasonably Related to the Intervention
Frequency Threshold:
0
Time Frame:
Adverse events were monitored/assessed in *each participant* from enrollment through study completion (end of funding), an average of 3.6 years. Specific amount of time for each individual is dependent upon when he/she entered the study and if/when they withdrew from the study.
Study:
NCT00854828
Study Brief:
A Multicenter Prospective Study of Quality of Life in Adult Scoliosis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Surgical Intervention-As Treated AE's Occurring While Patient Was in Surgical Arm | Surgical intervention: Surgical intervention as appropriate for adults with symptomatic lumbar scoliosis. AE's are reported in the treatment arm (surgical or non-operative) patient was in at time of AE. A total of 171 patients had surgical intervention. This number includes non operative patients who crossed over to surgical intervention. Some patients spent time and had AEs in both treatment arms. | 3 | None | 85 | 171 | 128 | 171 | View |
| Non-Operative Intervention-As Treated AE's Occurring While Patient Was on Non Operative Arm | Non-operative intervention: Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc. AE's are reported in the treatment arm (surgical or non-operative) patient was in at time of AE. A total of 150 had non operative interventions. | 2 | None | 41 | 150 | 70 | 150 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Genitourinary Event | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Surveillance, Epidemiology and End Results (SEER) Cancers | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Cardiac Events | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Gastrointestinal Events | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pulmonary Event | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Surgeries Unrelated to Adult Symptomatic Lumbar Scoliosis | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Circulatory Disorders | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Miscellaneous SAE | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Adult Lumbar Scoliosis Events | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Musculoskeletal Event (excluding spine related symptoms) | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Medication Reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Endocrine System Events | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Gastrointestinal Event | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Genitourinary Events | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Cardiac events | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Circulatory Events | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Hypertensive events | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Non SEER cancer | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Respiratory Events | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Infectious Event (non spine) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Psychosocial Events | NON_SYSTEMATIC_ASSESSMENT | Social circumstances | None | View |
| Reproductive | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Vision Events | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Misc events | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Cerebrospinal fluid leak (intra-op) | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Excessive blood loss/Intraop Coagulopathy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Ineffective fixation/Posterior element fracture | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Spinal implant failure (no revision) | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Proximal junctional kyphosis/breakdown (No revision required) | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Spine wound problems (Not requiring admission) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |