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 @ 11:15 PM
Ignite Modification Date: 2025-12-25 @ 8:52 PM
NCT ID: NCT04404556
Description: None
Frequency Threshold: 0
Time Frame: ~9 months
Study: NCT04404556
Study Brief: Diabetes Journey: An Adolescent Adherence Barriers Intervention
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Diabetes Journey Diabetes Journey is a web-based intervention to address key adherence barriers. Participants randomized to this arm will first receive the mandatory Introduction and Problem-Solving Module. Based on their elevations on the Barriers to Diabetes Adherence measure, participants will receive up to 7 modules in total. Participants will navigate through the web-based theme park map and complete modules independently and then will have accompanying Zoom telehealth sessions with a therapist. Diabetes Journey: Web-based telehealth intervention focused on adherence barriers and problem-solving 0 None 0 97 50 97 View
Enhanced Standard of Care Participants randomized to Enhanced Standard of Care will receive general education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) from each site across 12-weeks. Content to address adherence barriers were modified and or newly developed for the Enhanced Standard of Care group via the T1DToolkit website. Enhanced Standard of Care: General education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) will be provided. 0 None 1 65 39 65 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Increased suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Psychological Complications NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Medical complications not related to type 1 diabetes NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Medical complications related to type 1 diabetes NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Social complication NON_SYSTEMATIC_ASSESSMENT Social circumstances None View
Regulatory Issue NON_SYSTEMATIC_ASSESSMENT Investigations None View