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 @ 12:55 AM
Ignite Modification Date: 2025-12-25 @ 11:09 PM
NCT ID: NCT03168867
Description: None
Frequency Threshold: 0
Time Frame: 1 year, 6 months
Study: NCT03168867
Study Brief: Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth (3Ms)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard Educational Care Control Participants in the standard educational control group received education regarding type 1 diabetes management during their routine clinic visits. Education was consistent with the standard care provided by each of the study sites. 0 None 29 74 29 74 View
The 3Ms Intervention + Standard Educational Care The 3Ms was a brief e-health intervention delivered via an internet-based software application (CIAS) that incorporated principles of Motivational Interviewing. The goal of The 3Ms was to provide psychoeducation regarding the value of daily parental supervision of adolescent diabetes management and increase the primary caregiver's motivation to supervise adolescents' daily diabetes management. The intervention consisted of three brief 10-15 minute sessions delivered on a tablet computer during routine diabetes clinic appointments. 0 None 24 75 21 75 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Endocrine disorders None View
New Non-diabetes-Related Health Problem SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Blood glucose less than 50 mg/dL SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Worsening Diabetes-Related Health Problem SYSTEMATIC_ASSESSMENT Endocrine disorders None View
New Psychiatric Problem SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Domestic violence SYSTEMATIC_ASSESSMENT Social circumstances None View
New Diabetes-Related Health Problem SYSTEMATIC_ASSESSMENT Endocrine disorders None View
New Non-diabetes-Related Health Problem SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Problem with Parent-Child Relations SYSTEMATIC_ASSESSMENT Social circumstances None View
Psychiatric Problem SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
School Related Problem SYSTEMATIC_ASSESSMENT Social circumstances None View
Worsening Diabetes-Related Health Problem SYSTEMATIC_ASSESSMENT Endocrine disorders None View
New Family Problem SYSTEMATIC_ASSESSMENT Social circumstances None View