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 |
|---|---|---|---|---|---|---|---|---|
| Fat Responders (1) | receiving high-fat diet High-fat diet: The high-fat diet will consist of \~40% energy from fat and \~45% from carbohydrates. Protein will be 15% of energy. All participants will be assigned an energy intake target that will result in a daily deficit of \~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed | 0 | None | 1 | 46 | 0 | 46 | View |
| Carbohydrate Responders (1) | receiving high-fat diet High-fat diet: The high-fat diet will consist of \~40% energy from fat and \~45% from carbohydrates. Protein will be 15% of energy. All participants will be assigned an energy intake target that will result in a daily deficit of \~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed | 0 | None | 0 | 22 | 0 | 22 | View |
| Fat Responders (2) | receiving high-carbohydrate diet High-carbohydrate diet: The high-carbohydrate diet will consist of \~20% of energy from fat and \~65% from carbohydrates. Protein will be 15% of energy. All participants will be assigned an energy intake target that will result in a daily deficit of \~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed | 0 | None | 1 | 43 | 2 | 43 | View |
| Carbohydrate Responders (2) | receiving high-carbohydrate diet High-carbohydrate diet: The high-carbohydrate diet will consist of \~20% of energy from fat and \~65% from carbohydrates. Protein will be 15% of energy. All participants will be assigned an energy intake target that will result in a daily deficit of \~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed | 0 | None | 0 | 18 | 0 | 18 | View |