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 @ 5:44 PM
Ignite Modification Date: 2025-12-25 @ 3:12 PM
NCT ID: NCT03877068
Description: None
Frequency Threshold: 0
Time Frame: Information on adverse events was collected from the time consent to participate was given up to 10 days during hospitalization and up to 10 days after discharge (up to 20 days of monitoring).
Study: NCT03877068
Study Brief: Dexcom G6 Intervention Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dexcom G6 CGM System Participants wearing a real-time Dexcom G6 Continuous Glucose Monitoring (CGM), which provides blood glucose (BG) readings every 5 minutes during their hospital stay (up to 10 days). Participants also had point-of-care (POC) testing before meals and bedtime per hospital protocol. Insulin therapy was titrated based on daily CGM printouts, which included BG readings, glycemic excursions, hypoglycemia and severe hyperglycemia values throughout the day. Participants wore a CGM in the currently approved insertion sites of the abdomen and upper arm. 0 None 0 88 2 88 View
POC Blood Glucose Monitoring Participants receiving blood glucose (BG) monitoring by point-of-care (POC) testing before meals and at bedtime during their hospital stay (up to 10 days). Results were uploaded in the electronic medical record (EMR) system. Daily insulin was adjusted based on POC readings, per standard of care. Participants wore a 'blinded' CGM, where no results were visualized by participants, nursing staff, primary care physicians or members of the research team. 0 None 0 85 3 85 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Minor bleeding with sensor insertion NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View