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 |
|---|---|---|---|---|---|---|---|---|
| Flavoured Water Placebo for Acute Dosing | 500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate) | None | None | 0 | 10 | 0 | 10 | View |
| Sodium Citrate Dihydrate Acute | dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic) | None | None | 0 | 10 | 0 | 10 | View |
| Flavoured Water Placebo for Chronic Dosing | 500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate) | None | None | 0 | 10 | 0 | 10 | View |
| Sodium Citrate Dihydrate Chronic | 3 days of 0.1g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 milliliters of flavoured water Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic) | None | None | 0 | 10 | 0 | 10 | View |