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 |
|---|---|---|---|---|---|---|---|---|
| High Intensity Stepping Program | The high intensity stepping training consists of a 1-hour long physical therapy session administered by a physical therapist, and it will include overground walking, treadmill walking (with or without bodyweight support), stairs, and resisted walking. Heart rate will be monitored with the Polar heart rate monitor, with the goal of reaching moderate to high intensity for 30 minutes during the one hour-long physical therapy session. The training may involve the use of the Therastride Treadmill System or the VECTOR Bioness, and the device used will be determined by how much assistance the participant needs. If a participant is already ambulating and doesn't need assistance, then that participant won't use any equipment other than a Polar heart rate monitor. Therastride Treadmill System: Participants will walk on the Therastride Treadmill for 30 minutes. This treadmill can unweight patients so that the task of walking becomes easier. Body weight can be adjusted depending on how much assistance a patient needs from 0% of their bodyweight (completely independent) to up to 50% of their bodyweight. VECTOR Bioness: Participants will walk using the VECTOR Bioness on a track outside the gym with a harness attached to an overhead sling system. Body weight can be adjusted depending on how much assistance a patient needs from 0% of their bodyweight (completely independent) to up to 50% of their bodyweight. This system allows for overground walking on a small indoor track. | 0 | None | 0 | 4 | 0 | 4 | View |