Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 3:02 AM
Ignite Modification Date: 2025-12-26 @ 1:42 AM
NCT ID: NCT04241133
Description: Serious Adverse Event Data was collected about health measures that may lead to inpatient hospitalization, including hemoglobin A1c, blood pressure, lipid panel, and weight change.
Frequency Threshold: 0
Time Frame: 12 weeks during intervention
Study: NCT04241133
Study Brief: The UnProcessed Pantry Project (UP3)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Experimental Group A 12 week pilot trial was conducted at two rural food pantries in Montana with low-income adults to measure within-participant changes over time. The UnProcessed Pantry Project (UP3): UP3 used the Social-Ecological Model to target multiple levels, including the food supply in the rural study location (community level), the food environment at the food pantry (environmental level), and participant dietary intake (individual level). It was hypothesized that UP3 will improve access to minimally processed foods and decrease access to ultra-processed foods at the food pantry, which would improve overall dietary quality of individuals as measured by the Healthy Eating Index-2015 compared to baseline and to the control group. 0 None 0 44 0 44 View
Control Group Participants from a different food pantry were be enrolled into a control group with no intervention. The Healthy Eating Index-2015 was the primary outcome measure. 0 None 0 34 0 34 View
Serious Events(If Any):
Other Events(If Any):