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 @ 11:52 PM
Ignite Modification Date: 2025-12-25 @ 9:47 PM
NCT ID: NCT03141151
Description: None
Frequency Threshold: 0
Time Frame: Adverse Events were collected throughout the study. We specifically asked about adverse events and serious adverse events at each follow-up time point (4 months, 7 months, 1 year), but always completed follow-up and documentation for any event in between data collection time points.
Study: NCT03141151
Study Brief: Competency-based Approaches to Community Health
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
COACH: Healthy Bodies This will be a staged intensity behavioral intervention. The intensive phase will last 15 weeks and consist of weekly, 90 minute, skills-building sessions. The content will focus on diet, physical activity, sleep, media use, and parenting. Behavior change techniques will include goal-setting, self-monitoring, and problem solving. Following the intensive phase, participants will enter a maintenance phase, consisting of monthly phone calls from a health coach for 3 months. COACH: Healthy Bodies: Staged intensity behavioral intervention focusing on healthy lifestyles in the context of family. 0 None 0 59 0 59 View
COACH: Strong Minds This will be a school-readiness intervention for the 3-5 year old children involved, which will meet twice a month for 3 months. Group sessions will focus on building social support around literacy skills for parents and children, as well as school advocacy. COACH: Strong Minds: School Readiness Intervention focusing on literacy and parent skills 0 None 0 58 0 58 View
Serious Events(If Any):
Other Events(If Any):