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 |
|---|---|---|---|---|---|---|---|---|
| Total SubjectsAutism Spectrum Disorder (DSM IV & 5) | All children and adolescents seen for autism diagnostic evaluations at the study sites who meet diagnostic criteria for ASD in both DSM-IV and DSM-5 | 0 | None | 0 | 248 | 0 | 248 | View |
| Non-Autism Spectrum Disorder | All children and adolescents seen for autism diagnostic evaluations at the study sites who do not meet diagnostic criteria for ASD. | 0 | None | 0 | 160 | 0 | 160 | View |
| Autism Spectrum Disorder (DSM 5 Only) | All children and adolescents seen for autism diagnostic evaluations at the study sites who meet diagnostic criteria for ASD in DSM-5 but not DSM-IV | 0 | None | 0 | 1 | 0 | 1 | View |
| Autism Spectrum Disorder (DSM IV Only) | All children and adolescents seen for autism diagnostic evaluations at the study sites who meet diagnostic criteria for ASD in DSM-IV but not DSM-5 | 0 | None | 0 | 30 | 0 | 30 | View |