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 |
|---|---|---|---|---|---|---|---|---|
| Exercise and Cognitive Retraining | Aerobic exercise; Computerized cognitive retraining program; Heart failure education; Home visits; telephone follow-up. Exercise and Cognitive retraining: Walking 5 times per week at moderate intensity; cognitive retraining one-hour 2 times per week. | 0 | None | 0 | 19 | 0 | 19 | View |
| Exercise Only | Each participant will be provided with an individualized target heart rate (THR)zone based on treadmill results. Under the supervision of a research nurse, participants will begin the walking sessions at 60% of THR and increase to 70% by week 5. Participants will walk a minimum of 5 times per week for a duration of 30 minutes. Exercise Only | 0 | None | 0 | 29 | 0 | 29 | View |
| Stretching and Flexibility | Stretching and flexibility movements; heart failure education; home visits; telephone follow-up. Stretching and Flexibility | 0 | None | 0 | 21 | 0 | 21 | View |