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 |
|---|---|---|---|---|---|---|---|---|
| Beetroot Crystals (Nitrate) | Participants will receive a nitrate rich beetroot powder (10g/day) for 8 weeks. Super Beets: Nitrate rich beetroot powder (10g/day) for 8 weeks | 0 | None | 0 | 20 | 0 | 20 | View |
| Placebo (Beetroot Powder, no Nitrate) | Participants will receive a beetroot powder placebo (no nitrate) for 8 weeks. Super Beets Placebo: Nitrate deficient beetroot powder (10g/day) for 8 weeks | 0 | None | 0 | 19 | 0 | 19 | View |
| Nondiabetic Control Subjects | All pre supplementation measures and study visits will be performed in a group of 15 nondiabetic control subjects to allow us to 1) quantify the degree of impairment in T2D prior to intervention and 2) assess the effectiveness of the nitrate therapy in restoring the primary outcome measures back to 'normal'. Nondiabetic controls will not receive an 8-week beetroot supplementation. | 0 | None | 0 | 15 | 0 | 15 | View |