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 |
|---|---|---|---|---|---|---|---|---|
| Sodium Octanoate Breath Test | Only subjects with metabolic syndrome and suspected non alcoholic fatty liver disease will undergo breath test. They must not have any other liver disease. Sodium Octanoate Breath Test: 100 mg of 13-C labeled sodium octanoate (Octanoate for short) is to be dissolved in 1 cup of tap water and administered to subject after baseline breath collection is completed. | None | None | 0 | 61 | 4 | 61 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Lightheadedness | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Odiferous breath | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |