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 |
|---|---|---|---|---|---|---|---|---|
| Glucose Sensor | Continuous subcutaneous glucose monitoring using four different CGM systems in parallel will be performed throughout the study. Insulin therapy will be performed by the subjects themselves, as under daily life conditions. For the hypoglycaemia experiment an increased insulin bolus will be administered with meals (180% of the subject's calculated mealtime dose). Glucose Sensor: The investigational intervention is CGM monitoring using four different CGM systems. Three of the four CGM devices which are used will be CGM systems which have received conformité européenne (CE) certification (Dexcom G4 Platinum, Medtronic MiniMed 640G system, Abbott FreeStyle Libre Flash). The SPIDIMAN sensor will be used for the first time in human subjects, does not yet have received CE certification and will be given an identifying label in addition to being labelled "for investigative use only". | 0 | None | 0 | 12 | 3 | 12 | View |