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 | The subjects in the control arm will wear the 530G system using Enlite and MiniLink transmitter and threshold suspend. Control: Threshold suspend | None | None | 1 | 10 | 0 | 10 | View |
| Automatic Closed-loop Insulin Delivery | The closed-loop arm will consist of participants wearing a sensor and transmitter which transmits sensor glucose data. The algorithm determines insulin delivery rates and this is delivered in microboluses every 5 minutes Automatic closed-loop insulin delivery: Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes. | None | None | 0 | 11 | 0 | 11 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| hypoglcyemic seizure | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |