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 |
|---|---|---|---|---|---|---|---|---|
| Neuromuscular Electrical Stimulation | Subjects placed into this group will undergo NMES following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr for NMES therapy. NMES therapy post-reconstruction will commence immediately post-ACLr and end at week 6. Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week | None | None | 0 | 10 | 0 | 10 | View |
| Standard of Care | This group will undergo standard ACL rehabilitation | None | None | 0 | 10 | 0 | 10 | View |
| Combination of NMES and Eccentric Exercise | Subjects placed into this group will undergo a combined NMES and eccentric exercise intervention following ACLr. The NMES intervention will be delivered immediately following ACLr and will end at 6 weeks post-ACLr. Subjects will receive the NMES therapy 2 times per week for the first 6 weeks post-ACLr. At six weeks post-ACLr, subjects will begin the eccentric strengthening protocol. Subjects will eccentrically train 2 times per week for 6 weeks. The eccentric strengthening will end at 12 weeks post-ACLr. Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week | None | None | 0 | 8 | 0 | 8 | View |
| Eccentric Exercise | Subjects placed into this group will undergo eccentric exercise strength training following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr. Eccentric strengthening will begin at week 6 post-ACLr and will end at week 12 post-ACLr. Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week | None | None | 0 | 8 | 0 | 8 | View |