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 |
|---|---|---|---|---|---|---|---|---|
| LoBAG30 Diet | A LoBAG30, weight maintenance diet will be given to subjects on metformin. All food will be provided for 5 weeks. LoBAG30 diet: A LoBAG30 diet consists of 30% of total energy intake as carbohydrate, 30% protein, and 40% fat. | None | None | 0 | 7 | 0 | 0 | View |
| Control Diet | A weight maintenance, control diet consisting of 55% carbohydrate, 15% protein, 30% fat will be given to subjects on metformin. All food will be provided for 5 weeks. Control Diet: A control diet consists of 55% of total energy intake as carbohydrate, 15% protein, 30% fat | None | None | 0 | 7 | 0 | 0 | View |