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 @ 12:31 PM
Ignite Modification Date: 2025-12-25 @ 12:09 PM
NCT ID: NCT04678661
Description: None
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT04678661
Study Brief: My Dose Coach Mobile App to Support Insulin Titration and Maintenance
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intervention Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo. Phase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo. Patients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability. 2 None 0 60 15 60 View
Usual Care A retrospective comparative group was be selected from eligible patients who previously were treated at the University of Pittsburgh Medical Center (UPMC) Diabetes Outpatient Clinics following standard insulin therapy education. Patients in the usual care group were identified using data available in the electronic medical record system. Propensity score matching were used to pair intervention and usual care participants. 0 None 0 33 0 33 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mild Hypoglycemic Event SYSTEMATIC_ASSESSMENT Endocrine disorders None View