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:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
NCT ID:
NCT00534235
Description:
In place of serious adverse event (SAE), this study used Severe AE (reported in SAE section as device related Severe AE):
* is life threatening
* results in permanent impairment of a body function or permanent damage to a body structure; or
* necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure
Frequency Threshold:
0
Time Frame:
5 years
Study:
NCT00534235
Study Brief:
Post-Approval Clinical Trial Comparing the Long Term Safety and Effectiveness Coflex vs. Fusion to Treat Lumbar Spinal Stenosis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Posterolateral Fusion w/Pedicle Screws | Control: Posterolateral fusion and implantation of pedicle screws after decompression Decompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain Posterolateral Fusion and Implantation of Pedicle Screws | 0 | None | 64 | 107 | 101 | 107 | View |
| Coflex Interlaminar Technolgy | Investigative: Implantation of coflex Interlaminar Technology after decompression Decompression: Either microsurgical decompression or laminotomy to remove bone impinging on nerves causes the patient pain Implantation of coflex Interlaminar Technology | 0 | None | 109 | 215 | 199 | 215 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Component Loosening | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Component Breakage | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Tear > 5mm | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Hematoma Requiring Drainage | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Infection (deep) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Pain; new, increased frequency, or worsening | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Pseudarthrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Wound problems | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Other | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Cancer/Neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Cardiovascular | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Eye, Ear, Nose and Throat (EENT) | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Endocrine/Metabolic | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Gastrointestinal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Genitourinary | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hematological | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Musculoskeletal | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Neurological | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Psychiatric/Substance Abuse | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Respiratory | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Skin and Subcutaneous | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Component Loosening | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Component Migration | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Component Breakage | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Incidental Durotomy (<= 5mm) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Nerve Injury | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Pain; new, increased frequency, or worsening | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Pseudarthrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Wound problems | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Other | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Cancer/Neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Cardiovascular | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Eye, Ear, Nose, Throat (EENT) | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Endocrine/Metabolic | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Gastrointestinal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Genitourinary | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hematological | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Immune | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Musculoskeletal | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Neurological | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Psychiatric/Substance abuse | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Respiratory | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Skin and Subcutaneous Tissue | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |