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 |
|---|---|---|---|---|---|---|---|---|
| Time Restricted Eating (TRE) | For the TRE group, we will restrict the eating window to 8 hours, where they will eat ad libitum. This is the same interval established by Dr. Panda and by our preliminary data. This interval will be entered into the mCC app and participants will be asked to adhere to this eating window during the intervention. All eating occasions will be logged using the mCC app. Only water and medications will be allowed outside of the eating window. Time Restricted Eating (TRE): daily eating window restricted to 8 hours | 0 | None | 0 | 30 | 1 | 30 | View |
| Caloric Restriction (CR) | Participants randomized to CR will meet with the study dietitian prior to the intervention and be counseled on options to reduce their caloric intake by 15%, while maintaining their eating window. The 15% reduction was selected as our preliminary data and recent literature suggest that TRE with ad libitum intake reduces caloric intake by \~270 to 300 cal/day. The 15% CR is similar to the 11.9% CR achieved by the CALERIE-2 study, which is a 2 year study of CR.26 All eating occasions will be logged using the mCC app. The weekly dietitian review of the mCC information will include maintenance of the eating window and examination of dietary intake to determine compliance with the 15% CR. Caloric Restriction (CR): 15% daily caloric deficient | 0 | None | 0 | 29 | 1 | 29 | View |
| Unrestricted Eating (Non-TRE) | For the unrestricted eating (non-TRE) group, participants will eat ad libitum per their usual habits. They will receive initial counseling about mCC logging. All eating occasions will be logged using the mCC app. | 0 | None | 0 | 29 | 1 | 29 | View |