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: 2025-12-25 @ 12:00 AM
Ignite Modification Date: 2025-12-25 @ 9:57 PM
NCT ID: NCT04765358
Description: None
Frequency Threshold: 0
Time Frame: 26 Weeks
Study: NCT04765358
Study Brief: Virtual Diabetes Specialty Clinic: A Study Evaluating Remote Initiation of Continuous Glucose Monitoring
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Participants All participants were provided with a commercially available CGM system. Training and data collection for the study was completed remotely. After initial CGM training (initiation of unblinded CGM use or initial training with virtual clinic) was completed, participants were followed by the virtual clinic team for approximately six months. Psychosocial screening questionnaires were administered at enrollment and during follow up. The virtual clinical team member followed up with the study participant if there was an elevated score on the psychosocial screening questionnaires. After the initial six months of follow up, participants who decided to continue to use CGM were asked to extend follow up and complete questionnaires, submit HbA1c samples, and share data. During the extended follow up phase, participants were able to contact the virtual clinic with questions or to request assistance as needed. Virtual Clinic: CGM, Clinical Care Support and Behavioral Health Support 0 None 16 234 22 234 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Severe hypoglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hospitalization SYSTEMATIC_ASSESSMENT General disorders None View