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 |
|---|---|---|---|---|---|---|---|---|
| Control Condition | Participants randomly assigned to the control condition will be asked to continue their usual physical activity habits and will not interact with the intervention staff. | 0 | None | 0 | 23 | 0 | 23 | View |
| Exergaming Condition | Participants randomly assigned to the exergaming condition will participate in a 6 month exergaming intervention. Exergaming Condition: Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines. | 0 | None | 0 | 23 | 2 | 23 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Injury during game play | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |