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 |
|---|---|---|---|---|---|---|---|---|
| Resin Infiltration | After radiographic and SFE imaging to assess lesion depth, the study lesions were treated using the resin infiltrant Icon (DMG, Germany) according to manufactures´ instructions. | 0 | None | 0 | 5 | 0 | 5 | View |
| Fluoride Varnish & Oral Hygiene Instruction | After radiographic and SFE imaging to assess lesion depth oral hygiene instruction and topical fluoridation therapy were provided. For topical fluoridation Duraphat Fluoride Varnish (Colgate, USA) has been used according to manufactures´ instructions. | 0 | None | 0 | 7 | 0 | 7 | View |