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 |
|---|---|---|---|---|---|---|---|---|
| Control, no Supplement | Each visit corresponding to a standardize breakfast taken alone (control visit)followed by a period of 4-hour with multiple blood sampling. | None | None | 0 | 10 | 0 | 10 | View |
| 5g of Leucine | Each visit corresponding to a standardize breakfast taken with 5g of leucine followed by a period of 4-hour with multiple blood sampling. | None | None | 0 | 10 | 0 | 10 | View |
| 3.6g de Butyrate | Each visit corresponding to a standardize breakfast taken with 3.6g of butyrate followed by a period of 4-hour with multiple blood sampling. | None | None | 0 | 10 | 2 | 10 | View |
| 7.2g de Butyrate | Each visit corresponding to a standardize breakfast taken with 7.2g of butyrate followed by a period of 4-hour with multiple blood sampling. | None | None | 0 | 10 | 3 | 10 | View |
| 5g d'Octanoate | Each visit corresponding to a standardize breakfast taken with 5g of octanoate followed by a period of 4-hour with multiple blood sampling. | None | None | 0 | 10 | 2 | 10 | View |
| 10g d'Octanoate | Each visit corresponding to a standardize breakfast taken with 10g of octanoate followed by a period of 4-hour with multiple blood sampling. | None | None | 0 | 10 | 3 | 10 | View |
| 1.95g de Carnitine | Each visit corresponding to a standardize breakfast taken with 1.95g of carnitine followed by a period of 4-hour with multiple blood sampling. | None | None | 0 | 10 | 0 | 10 | View |