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 @ 1:23 AM
Ignite Modification Date: 2025-12-25 @ 11:33 PM
NCT ID: NCT04246593
Description: This is a low risk study. We do not anticipate any harm to the participants. Study staff reported adverse events to the PI within 24 hours and the PI reported all adverse events in accordance with the policy of the UB IRB. Because of this low risk status, the data safety monitoring plan (DSMP) focused on close monitoring, along with prompt reporting of excessive adverse events and any serious adverse events to the NIH and to the IRB. Recruitment, drop-out, and missing data will be reviewed.
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT04246593
Study Brief: Effectiveness and Implementation of a Research Tested Mobile Produce Market
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 - Market Partner sites that are randomized to the "Intervention - Market" will plan and start (or expand) a Mobile Market and run the Market weekly for at least 10 months (non necessarily nonconsecutive). The Mobile Market will follow the Veggie Van Model which includes a "share model", price reductions (incentives), and an educational component. Mobile Market program implementation: Mobile Market program implementation includes utilizing a Veggie Van model which sells reduced cost locally-grown produce in communities with barriers to accessing fresh F\&Vs because of availability, cost, or lack of produce preparation skills.The Veggie Van visits sites that already serve the target market (e.g., lower-income housing communities, community health centers, community colleges). While Mobile Market programs vary in their model and operation, we believe that the three components of Veggie Van's success are it's "share" model, price reductions (incentives), and educational component 0 None 0 426 0 426 View
Control - Planning At Control - Planning (comparison) sites, engagement will focus on involving community members in food access program planning and research. It is anticipated that each organization will create one or more community advisory committees to oversee their food access work. At comparison sites, engagement efforts will be more generally centered on food access and understanding what types of programs would be most acceptable. Examples of community engagement activities include community forums and listening sessions, informational tables at community events, and establishment of text, e-mail or social media sites for ongoing communication and feedback around food access issues. As part of this community engagement work, partners will collect contact information from community members that will assist in the data collection process. 0 None 0 273 0 273 View
Serious Events(If Any):
Other Events(If Any):