Adverse Events Module

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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

Ignite Creation Date: 2025-12-25 @ 2:18 AM
Ignite Modification Date: 2025-12-26 @ 12:49 AM
NCT ID: NCT05516134
Description: Long-term care communities were asked to let the Principal Investigator (PI) know (via email, phone, or in person) about adverse events if/when they occur. In addition, each long-term care community was contacted via email at the end of each month by the PI. In that email, the PI asked the long-term care community whether any adverse events occurred that had not yet been reported. Staff and family members were also assessed for events, but not the target of the intervention.
Frequency Threshold: 0
Time Frame: 11 weeks
Study: NCT05516134
Study Brief: All About Me: An Intervention to Ease the Transition to Long Term Care
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment Participants with dementia who received the intervention. The intervention is called All About Me (AAM, which consists of Serious Digital Health Games for PWD, includuing the The Fun Facts About Me Game and the Resident Game Bundle (e.g., Survey Says). 0 None 0 26 0 26 View
Family Members family members who played game with person with dementia 0 None 0 9 0 9 View
Staff Members staff who took training and gave feedback about the app 0 None 0 16 0 16 View
Serious Events(If Any):
Other Events(If Any):