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 Clinical Practice (UCP) | UCP participants received the same clinical and educational management for candidates for insulin pump or continuous glucose monitoring that was received by similar patients who were not enrolled in this study. The respective endocrinology practices at the enrolling sites all strive to meet or exceed the current American Diabetes Association Standards for Clinical Practice in the management of type 1 diabetes in this population. Thorough patient education is the cornerstone of that care, especially regarding the incorporation of insulin pumps and continuous glucose monitors into the treatment regimen for a given patient. Usual Clinical Practice: Diabetes management and education related to insulin pump or continuous glucose monitor as currently practiced at the enrolling site. | 0 | None | 0 | 67 | 0 | 67 | View |
| Shared Medical Decision Making (SMDM) | Participants randomized to SMDM received all components of UCP supplemented with access to the decision aid website pertinent to the medical decision of interest (pump or CGM). Adolescents and parents received password-protected, secure access to the decision for their use until a decision is reached. The platform then generated a summary report that the adolescent and parent could discuss with a diabetes nurse and then a visit with the treating endocrinologist was scheduled to conclude the SMDM intervention for that adolescent and parent. Shared Medical Decision Making: Access to and use of multimedia decision aid websites to facilitate adolescent and parent decision making about incorporating these devices into the diabetes management regimen. | 0 | None | 0 | 67 | 0 | 66 | View |