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 |
|---|---|---|---|---|---|---|---|---|
| Visual Analog Scale, Dental Cleaning | Dental cleaning and performing the visual analog scale. At first visit was doing Dental cleaning and visual analog scale and after 90 days was doing another visual analog scale. | 0 | None | 0 | 7 | 0 | 7 | View |
| Visual Analog Scale,Dental Cleaning,Occlusal Adjustment. | Dental cleaning, occlusal adjustment, and visual analog scale and gnathostatic models was doing in the intervention group, at the first visit. After 90 days, visual analog scale, and gnathostatic models, was doing again. | 0 | None | 0 | 14 | 0 | 14 | View |