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 |
|---|---|---|---|---|---|---|---|---|
| Artificial Pancreas (Closed Loop Control) | Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes. Artificial Pancreas: Use of CTR at home for 3 months | 0 | None | 1 | 65 | 0 | 65 | View |
| Sensor Augmented Therapy | Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Sensor Augmented Therapy: Use of personal pump with study CGM \& glucometer at home for 3 months | 0 | None | 0 | 62 | 2 | 62 | View |