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 |
|---|---|---|---|---|---|---|---|---|
| CCRT Intervention | Intervention is a Computer Cognitive Rehabilitation Training delivered in 24 sessions over 8 weeks (3 times/week) Computerized cognitive rehabilitation therapy (CCRT): 8 weeks of 3 times weekly intervention for 45 min per session with Captain's Log program | 0 | None | 0 | 51 | 0 | 51 | View |
| Control | Passive Control with no intervention training for 8 weeks | 0 | None | 0 | 54 | 0 | 54 | View |
| Limited CCRT | Locked CCRT that does not become more difficult with mastery of child on computer games training Limited CCRT active control intervention: Locked Captain's Log CCRT that rotates randomly among simplest level of computer cognitive games training | 0 | None | 0 | 52 | 0 | 52 | View |