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 |
|---|---|---|---|---|---|---|---|---|
| Routine Clinical Care Plus Enhanced Genomic Report | Routine clinical care and access to the enhanced genomic lab report upon completion of the baseline survey. Participants in this arm will receive only one survey at 3 months post enhanced report. | 0 | None | 0 | 28 | 0 | 28 | View |
| Routine Clinical Care First, Then Enhanced Report | Participants will receive routine clinical care with a copy of their standard laboratory report. After completion of the 3 month survey, participants will receive the enhanced report, followed by another survey 3 months after receiving the enhanced report. | 0 | None | 0 | 24 | 0 | 24 | View |