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-based Cognitive Behavioral Intervention | Subjects receiving the group-based CT-CB intervention Group-based Cognitive Behavioral Intervention: This intervention will include six 1-hour group sessions held biweekly for twelve weeks. Each sixty-minute session will consist of 15 minutes of diabetes education regarding exercise and food planning and approximately 45 minutes of CT-CB presentations/engagement activities. Participants will be encouraged to bring along their family members or friends for support. | 0 | None | 0 | 7 | 0 | 7 | View |
| Web-based Cognitive Behavioral Intervention | Subjects receiving the web based CT-CB intervention Web-based Cognitive Behavioral Intervention: This intervention will include six 1-hour web-based sessions held biweekly for twelve weeks. Subjects in the web-based CT-CB will be asked to reserve a 1 hour period for a web call from the Behavioral Interventionist team. Text reminders will be sent to the participants prior the sessions. During this period, approximately 15 minutes will be reserved for diabetes exercise and food planning education and approximately 45 minutes of CT-CB engagement activities. | 0 | None | 0 | 7 | 0 | 7 | View |
| Usual Care | Subjects receiving usual care from their primary care providers Usual Care: Usual care group participants will continue to receive care and follow up from their primary care providers as per the American Diabetes Association guidelines with log books, education regarding self-management strategies and appropriate referrals as needed. | 0 | None | 0 | 0 | 0 | 0 | View |