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 |
|---|---|---|---|---|---|---|---|---|
| Educational Material | Participants will be given written educational material to encourage dietary change towards a better quality diet. Educational material will be adapted from resources used in previous dietary intervention studies. | 0 | None | 0 | 74 | 0 | 74 | View |
| Personalised Dietary Advice and Educational Material | Participants will also be given the educational material, but will be encouraged to make dietary change using individualized recommendations incorporating food markers of specific components of a high quality diet. Food markers of diet quality will be used to develop an algorithm to deliver personalized dietary advice. Based on biomarker data, a system of categorization of biomarker status will be developed, alongside dietary advice related to this biomarker categorization, and decision trees created, as previously described in the Food4Me study, to ensure standardized delivery of advice within this intervention arm. | 0 | None | 0 | 75 | 0 | 75 | View |