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 @ 9:33 PM
Ignite Modification Date: 2025-12-25 @ 7:17 PM
NCT ID: NCT03595332
Description: None
Frequency Threshold: 0
Time Frame: 1 year
Study: NCT03595332
Study Brief: Addressing Health Disparities in Childhood Obesity, One Summer at a Time
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Immediate Intervention: Immediate Group Summer activity program: Children received the summer scorecard program during the first summer of the 2-year study. Summer activity program: Children received a summer scorecard to facilitate access to local facilities for exercise. 0 None 0 92 0 92 View
Immediate Intervention: Delayed Group The Delayed intervention group did not receive any intervention during the first summer of the 2-year study. 0 None 0 130 0 130 View
Delayed Intervention: Immediate Group The Immediate intervention group did not receive any intervention during the second summer of the 2-year study. 0 None 0 92 0 92 View
Delayed Intervention: Delayed Group Summer activity program: Children received the summer scorecard program during the second summer of the 2-year study. Summer activity program: Children received a summer scorecard to facilitate access to local facilities for exercise. 0 None 0 130 0 130 View
Serious Events(If Any):
Other Events(If Any):