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 |
|---|---|---|---|---|---|---|---|---|
| hrCTR | The experimental admission (hrCTR) was defined as having the participant complete a exercise session where the Diabetes Assistant (DiAs) Control-to-Range system is notified of heart rate. The study team member activated and deactivated a heart rate button when the subject's heart rate exceeded and then returned below 140 beats per minute. The admission was about 24-hour in duration with at least 2 days of wash-out in between. Admission had to be completed within a 2-month window. | 0 | None | 0 | 18 | 0 | 18 | View |
| No hrCTR | The control admission (no hrCTR) had participants complete an exercise session where the closed loop is not informed about heart rate. The admission was about 24-hour in duration with at least 2 days of wash-out in between. Admission had to be completed within a 2-month window. | 0 | None | 0 | 18 | 0 | 18 | View |