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 |
|---|---|---|---|---|---|---|---|---|
| MOVE-IT Home Exercise Program (HEP) | Participants will be asked to employ the MOVE-IT system for upper extremity practice at home 1 hour/day, 5 days/week over a 10-week period. MOVE-IT Intervention: The MOVE-IT device comprises a custom smart toy and therapy game software to enable repetitive task practice involving the arm and hand. | 0 | None | 0 | 11 | 0 | 11 | View |
| Usual Care Treatment (UCT) Control | Children in the UCT group will be followed as they continue to receive their previously prescribed therapy services. These children will not receive any treatment services through the study as UCT group participants. UCT Control: Participants assigned to the UCT control group will continue to receive their previously prescribed therapy services. | 0 | None | 0 | 10 | 0 | 10 | View |