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 |
|---|---|---|---|---|---|---|---|---|
| Control SAP Group | The control SAP group used their home insulin pumps. All participants were fitted with a Dexcom CGM G5 continuous glucose monitor with Share™ capability with minimum calibration before breakfast and dinner (7:00 A.M. and 7:00 P.M.) using a study-provided blood glucose meter (BGM) (ContourNext Link; Ascencia Diabetes Care, Parsippany, NJ). | 0 | None | 0 | 24 | 0 | 24 | View |
| Experimental AP Group | The experimental AP Group used the Tandem t:slim X2 with Control-IQ Technology (Tandem Diabetes Care, San Diego, CA) which was integrated with the Dexcom G6 CGM (Dexcom, San Diego, CA). | 0 | None | 0 | 24 | 0 | 24 | View |