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 |
|---|---|---|---|---|---|---|---|---|
| Normal Hearing | Normal hearing: according to the WHO classification was defined as a PTA below 25dB (0.5-4 kHz) bilaterally. | 0 | None | 0 | 28 | 0 | 28 | View |
| Mild BHL | Mild BHL: according to the WHO classification was defined as a PTA between 25-40dB BHL(0.5-4 kHz) in the better ear. | 0 | None | 0 | 16 | 0 | 16 | View |
| > Moderate BHL | Moderate BHL: according to the WHO classification was defined as a PTA between 41-55dB BHL(0.5-4 kHz) in the better ear. Moderately-severe BHL: according to the WHO classification was defined as a PTA between 56-70 BHL(0.5-4 kHz) in the better ear. Severe BHL: according to the WHO classification was defined as a PTA between 71-90dB BHL(0.5-4 kHz) in the better ear. Profound BHL: according to the WHO classification was defined as a PTA between 91+ dB BHL(0.5-4 kHz) in the better ear. | 0 | None | 0 | 15 | 0 | 15 | View |