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 |
|---|---|---|---|---|---|---|---|---|
| Auditory Remediation With Active tDCS | Auditory remediation program paired with active transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week Active Transcranial direct current stimulation (tDCS): Active tDCS, where an extremely weak electric current passes through the brain Auditory Remediation: Computer program designed to improve discrimination between sounds | 0 | None | 0 | 2 | 1 | 2 | View |
| Auditory Remediation With Sham tDCS | Auditory remediation program paired with sham transcranial direct current stimulation (tDCS) for 30 minutes, 2-3 sessions per week Sham Transcranial direct current stimulation (tDCS): Sham (inactive or placebo) tDCS Auditory Remediation: Computer program designed to improve discrimination between sounds | 0 | None | 0 | 3 | 0 | 3 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| sedation | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |