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: 2025-12-25 @ 1:46 AM
Ignite Modification Date: 2025-12-26 @ 12:04 AM
NCT ID: NCT02826694
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data was collected beginning at Baseline and continued through Time 4 (3 months after results visit).
Study: NCT02826694
Study Brief: North Carolina Newborn Exome Sequencing for Universal Screening
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Well Infant, Whole Exome Sequencing Healthy infants and their parents enrolled in the study prenatally will participate. After the infant is born saliva sample will be collected for DNA extraction and whole exome sequencing will be done. Well infant, whole exome sequencing: Whole exome sequencing will be performed in children with diagnosed conditions. Investigators will analyze results that are associated with their condition. 0 None 0 61 0 61 View
Diagnosed, Whole Exome Sequencing Infants and children with diagnosed conditions whose parents enroll in the study and consent to having their child sequenced will have saliva samples obtained and whole exome sequencing will be done on extracted DNA. Diagnosed, whole exome sequencing: In addition to returning results of conditions associated with a child's phenotype, investigators will also analyze genes that are associated with conditions that have childhood onset and are medically actionable. 0 None 0 45 2 45 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sample mixup NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View