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 | These participants will participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax. Exercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax. | 0 | None | 0 | 20 | 0 | 20 | View |
| Alternate Day Fasting | These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". Alternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". | 0 | None | 0 | 20 | 0 | 20 | View |
| Combination Alternate Day Fasting Plus Exercise | These participants will consume 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". They will also participate in a supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax. Alternate day fasting: The diet involves consuming 600 kcal on the "fast day" and eat ad libitum at home on alternating "feed days". Exercise: The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session, 60-85% HRmax. | 0 | None | 0 | 20 | 0 | 20 | View |
| Control | Controls will be instructed to maintain their weight throughout the trial, and not to change eating or physical activity habits. | 0 | None | 0 | 20 | 0 | 20 | View |