Adverse Events Module

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 @ 9:43 PM
Ignite Modification Date: 2025-12-25 @ 7:24 PM
NCT ID: NCT03211832
Description: Clinical adverse event data were not collected because there were no study outcomes involving a health behavior, a disease or health condition, a symptom, or health status. Outcomes were perceived capacity for and organizational supports for use of evidence-based decision making among public health department employees. The main risk to participants was loss of confidentiality of survey response, which was monitored. No losses of confidentiality were found by or reported to the study team.
Frequency Threshold: 0
Time Frame: None
Study: NCT03211832
Study Brief: Disseminating Public Health Evidence to Support Prevention and Control of Diabetes Among Local Health Departments
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control The control group will conduct usual public health practice. 0 None 0 0 0 0 View
Intervention Participating local health departments will help develop and choose several dissemination activities they prefer for their local health department to receive. Dissemination activities may include multi-day in-person training workshops, electronic information exchange modalities, remote technical assistance, and information on ways to enhance organizational climates favorable to evidence-based diabetes and chronic disease prevention and control. Dissemination of public health knowledge: Participating local health departments will help develop and choose dissemination strategies they prefer for their staff working in and supporting diabetes and chronic disease prevention and control to receive. Dissemination strategies may include multi-day in-person training workshops, electronic information exchange modalities, remote technical assistance, and information on ways to enhance organizational climates favorable to evidence-based diabetes prevention and control. 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):