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:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
NCT ID:
NCT00697827
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00697827
Study Brief:
A Study of the In-Space Device for Treatment of Moderate 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 |
|---|---|---|---|---|---|---|---|---|
| In-Space | The treatment group consists of patients who receive the In-Space device. The In-Space is indicated for patients experiencing intermittent neurogenic claudication secondary to degenerative lumbar stenosis. Moderate degenerative lumbar stenosis is further defined by moderately impaired physical function in patients who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of conservative treatment, and who otherwise would not be treated by a surgical decompression. The In-Space is intended to be implanted between the spinous processes of 1 or 2 contiguous lumbar motion segments between L1 and L5. | None | None | 19 | 28 | 21 | 28 | View |
| X-Stop | The control group consists of patients who receive X STOP which is an appropriate control as the X STOP is FDA-approved. The X-Stop Interspinous Process device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis. The X-Stop may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels. | None | None | 9 | 16 | 13 | 16 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Infection | None | Infections and infestations | None | View |
| Back and Lower Extremity Pain | None | Musculoskeletal and connective tissue disorders | None | View |
| Respiratory | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Index Level Surgery | None | Surgical and medical procedures | None | View |
| Surgery - not Index Level | None | Surgical and medical procedures | None | View |
| Cardiovascular | None | Cardiac disorders | None | View |
| Fracture Spine - not Spinous Process | None | Musculoskeletal and connective tissue disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Spinous Process Fracture | None | Musculoskeletal and connective tissue disorders | None | View |
| Non-spine Fractures | None | Musculoskeletal and connective tissue disorders | None | View |
| Gastrointestinal | None | Gastrointestinal disorders | None | View |
| Genitourinary | None | Renal and urinary disorders | None | View |
| Headache | None | General disorders | None | View |
| Non-wound related Infection | None | Infections and infestations | None | View |
| Insomnia | None | General disorders | None | View |
| Musculoskeletal | None | Musculoskeletal and connective tissue disorders | None | View |
| Musculoskeletal spasms back | None | Musculoskeletal and connective tissue disorders | None | View |
| Neurological | None | Nervous system disorders | None | View |
| Numbness non-index level related | None | Nervous system disorders | None | View |
| Other | None | General disorders | None | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | None | View |
| Pain - back and other | None | Musculoskeletal and connective tissue disorders | None | View |
| Pain - incision site | None | General disorders | None | View |
| Pain - lower extremities | None | Musculoskeletal and connective tissue disorders | None | View |
| Pain - neck | None | Musculoskeletal and connective tissue disorders | None | View |
| Pain - neck and other | None | Musculoskeletal and connective tissue disorders | None | View |
| Pain - other | None | General disorders | None | View |
| Pain - shoulder | None | Musculoskeletal and connective tissue disorders | None | View |
| Psychological | None | Psychiatric disorders | None | View |
| Sore throat | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Stroke | None | Nervous system disorders | None | View |
| Wound issues other | None | General disorders | None | View |