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 |
|---|---|---|---|---|---|---|---|---|
| Increase Sweet Food Consumption | Participants are asked to increase their consumption of sweet foods throughout their diet. Participants will be supported through an individual dietary interview where sweet foods will be highlighted and additional sweet food consumption recommended. Sweet food consumption: Comparison of the impacts of sweet and non-sweet food consumption | 0 | None | 0 | 21 | 0 | 21 | View |
| Decrease Sweet Food Consumption | Participants are asked to decrease their consumption of sweet foods throughout their diet. Participants will be supported through an individual dietary interview where sweet foods will be highlighted and substitutions for sweet food consumption will be recommended. Sweet food consumption: Comparison of the impacts of sweet and non-sweet food consumption | 0 | None | 0 | 15 | 0 | 15 | View |