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 |
|---|---|---|---|---|---|---|---|---|
| Usual Care | Caregivers randomized to UC will be sent general material about VA and community resources for patients with dementia and their CGs. With the exception of this material, individuals in this group will receive usual care and will be contacted again at 3, 6, and 12 months for follow-up research assessments. | 0 | None | 3 | 112 | 0 | 112 | View |
| Individual Delivered TEP Arm | Two mandatory modules that cover the stages of dementia and provide a brief introduction to problem solving techniques, action plan development, and coping skills, plus a menu of additional modules covering various content areas evaluated during the course of the monthly assessments (e.g., communication skills, behavioral management techniques, stress management and coping skills, longterm planning, etc.). Each individual TEP session will begin with reviewing education related to the selected module. The remainder of each session will involve coaching the caregiver on emotion-focused and problem focused coping strategies. The care manager will also discuss problem solving with the CG to reinforce the action plan and the educational component of the intervention. | 0 | None | 7 | 122 | 0 | 122 | View |
| Group Delivered TEP Arm | All TEP modules will be in a group format. Each call will take 1.5-2 hours. Each group will be comprised of 5-8 CGs who will call into a teleconference line at a pre-specified time. Groups will include spouse/partner-only or adult child-only CGs. The content of the calls will mirror those in the individual TEP delivered program. In addition to the group calls, they will receive individual care management. | 0 | None | 6 | 85 | 0 | 85 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hospitalization due to surgery | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hospitalization - Illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hospitalization/ER | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Surgery | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |