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 |
|---|---|---|---|---|---|---|---|---|
| Xylitol GB | Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant Xylitol gummy bears: The children receive xylitol gummy bears 3 times/day within the supervised school environment. Oral health education: Oral health education, toothbrush, and fluoride toothpaste Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base. Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted. | None | None | 0 | 260 | 0 | 260 | View |
| Fiber GB | Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant Sugar free fiber gummy bears: The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment. Oral health education: Oral health education, toothbrush, and fluoride toothpaste Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base. Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted. | None | None | 0 | 265 | 0 | 265 | View |