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 |
|---|---|---|---|---|---|---|---|---|
| Group I Supportive Care (Prepare to Care Kit) | Caregivers watch introduction video on a DVD over 10 minutes at baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session over 10-30 minutes weekly. Communication Intervention: Attend interventionist sessions Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated. | 0 | None | 0 | 17 | 0 | 17 | View |
| Group II Control Group | Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study. Watch video: Watch video on a DVD Module completion of the Prepare to Care kit: Complete modules of the Prepare to Care kit Quality-of-Life Assessment: Ancillary studies Survey Administration: Ancillary studies Salivary cortisol collection: Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated. | 0 | None | 0 | 18 | 0 | 18 | View |