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 |
|---|---|---|---|---|---|---|---|---|
| Spring 2018 Participation | Students in this arm (40 per school, up to 120 total) will participate in the BOKS program in Winter-Spring 2018. They will serve as the control group in Fall 2018. BOKS Program: 12-week physical activity program, occurring 3x/week, lasting 30-60 minutes per session. | 0 | None | 0 | 86 | 0 | 86 | View |
| Fall 2018 Participation | Students in this arm (40 per school, up to 120 total) will participate in the BOKS program in Fall 2018. BOKS Program: 12-week physical activity program, occurring 3x/week, lasting 30-60 minutes per session. | 0 | None | 0 | 42 | 0 | 42 | View |