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 |
|---|---|---|---|---|---|---|---|---|
| Standard of Care Group | Standard of Care group will receive the standard, face-to-face hearing aid fitting and verification approach standard hearing aid fitting: standard hearing aid, face-to-face fitting | 0 | None | 0 | 22 | 0 | 22 | View |
| Average RECD Group | This group will have their hearing aid fitting via the coupler using average RECD values during the fitting coupler-based fitting: coupler-based fitting using average RECDs | 0 | None | 0 | 24 | 0 | 24 | View |
| Measured RECD Group | This group will have their hearing aid fitting via the coupler using measured RECD values during the fitting coupler-based fitting: coupler-based fitting using measured RECDs | 0 | None | 0 | 26 | 0 | 26 | View |