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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Flexibility Exercise Group | \*\*Stretching exercise(control) * Only educate the flexibility exercise(stretching exercise) * Don't educate the walking exercise method and stabilization exercise method | 0 | None | 0 | 13 | 0 | 13 | View |
| Walking Exercise Group | \*\*walking exercise with bracing exercise * walking exercise: treadmill gait with tolerable gait speed * bracing exercise: patient is instructed as follows: "Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this." exercise: -stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition. * bracing exercise: patient is instructed as follows: "Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this." * walking exercise: treadmill gait with tolerable gait speed * flexibility exercise: stretching exercise(control) | 0 | None | 0 | 13 | 0 | 13 | View |
| Stabilization Exercise Group | \*\* stabilization exercise •stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition. | 0 | None | 0 | 10 | 0 | 10 | View |
| Walking and Stabilization Exercise Group | \*\*walking exercise with stabilization exercise * stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition. * walking exercise:treadmill gait with tolerable gait speed | 0 | None | 0 | 12 | 0 | 12 | View |