Adverse Events Module

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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

Ignite Creation Date: 2025-12-24 @ 2:07 PM
Ignite Modification Date: 2025-12-25 @ 12:49 PM
NCT ID: NCT02065895
Description: Adverse events were to be reported to the CCI in accordance with CCI policy (Section XII, G of the CCI Policy and Procedure manual) on reporting such events
Frequency Threshold: 0
Time Frame: Study data was collected over a 6 month period, in the Center for Clinical Investigations at the Beth Israel Deaconess Medical Center
Study: NCT02065895
Study Brief: Effect of Gain on Closed-Loop Insulin
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
HIGH Error First, LOW Error Second, NO Error Third Nighttime and Breakfast closed-loop glucose control was performed on 3 occasions: first with the glucose value used for control calculated to be 33% higher than the true glucose (HIGH error), then with the value calculated to be 80% of the true value (LOW error), and then with the value equal to the true glucose (NO error). 0 None 0 1 0 1 View
NO Error First, LOW Error Second, HIGH Error Third Nighttime and Breakfast closed-loop glucose control was performed on 3 occasions: first with the glucose value used for control equal to the true glucose (NO error), then with the value calculated to be 80% of the true value (LOW error) and then with the value calculated to be 33% higher than the true glucose (HIGH error) 0 None 0 1 0 1 View
LOW Error First, HIGH Error Second, NO Error Third Nighttime and Breakfast closed-loop glucose control was performed on 3 occasions: first with the glucose value used for control calculated to be 20% lower than the true glucose (LOW error), then with the value calculated to be 30% higher than the true value (HIGH error) and then with the value equal to the true glucose (NO error) 0 None 0 1 0 1 View
HIGH Error First, NO Error Second, LOW Error Third Nighttime and Breakfast closed-loop glucose control was performed on 3 occasions: first with the glucose value used for control calculated to be 33% higher than the true glucose (HIGH error), then with the value equal to the true glucose (NO error), and then with the value calculated to be 80% of the true value (LOW error). 0 None 0 2 0 2 View
NO Error First, HIGH Error Second, LOW Error Third Nighttime and Breakfast closed-loop glucose control was performed on 3 occasions: first with the glucose value used for control equal to the true glucose (NO error), then with the value calculated to be 33% higher than the true glucose (HIGH error), and then with the value calculated to be 80% of the true value (LOW error). 0 None 0 1 0 1 View
LOW Error First, NO Error Second, HIGH Error Third Nighttime and Breakfast closed-loop glucose control was performed on 3 occasions: first with the glucose value used for control equal 80% of the true value (LOW error), then with value equal to the true glucose (NO error), and then with the value calculated to be calculated to be 33% higher than the true glucose (HIGH error). 0 None 0 1 0 1 View
Serious Events(If Any):
Other Events(If Any):