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 |
|---|---|---|---|---|---|---|---|---|
| VNS Treatment | Vagus nerve stimulation and tones are used 2.5 hours per day for a 6-week period. VNS Treatment: VNS is given in brief bursts over a 2.5 hour period. The subject also has headphone connected to a computer, and hears audio tones through the headphones that occur during VNS. | None | None | 1 | 16 | 2 | 16 | View |
| VNS Control | Vagus nerve stimulation and tones are given daily over a 2.5 hour period, but not in the same way as the experimental group, and in such a way that it is believed to be ineffective but still provide both VNS and tones so that blinding is maintained. VNS Control: This is the sham-control group; subjects in this group will receive both tones and VNS, but in a manner that is expected to be ineffective. | None | None | 2 | 14 | 1 | 14 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Coughing | None | Respiratory, thoracic and mediastinal disorders | None | View |