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 @ 11:58 AM
Ignite Modification Date: 2025-12-25 @ 11:56 AM
NCT ID: NCT04084561
Description: None
Frequency Threshold: 0
Time Frame: 1 day
Study: NCT04084561
Study Brief: Risk Communication in African American Smokers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
LRHA Low Risk, High Ancestry LRHA: participants will receive "Low Risk, High Ancestry (HRLA)" hypothetical 0 None 0 42 0 42 View
HRHA High Risk, High Ancestry HRHA: participants will be asked to consider a hypothetical scenario in which genetic test results reveal that: 1) they carry genotypes that place African American smokers at a particularly high (\~50%-80%) risk for the development of lung cancer, and 2) their genetic profile reflects a particularly high concordance with African heritage (\~90%). 0 None 0 41 0 41 View
LRLA Low Risk, Low Ancestry LRLA: participants will be asked to consider a scenario in which genetic test results reveal that: 1) they are at normal (\~7%-10%) risk for the development of lung cancer, and 2) their genetic profile reflects a particularly low concordance with African heritage (\~10%). 0 None 0 40 0 40 View
HRLA High Risk, Low Ancestry HRLA: participants will receive "High Risk, Low Ancestry (HRLA)" hypothetical 0 None 0 43 0 43 View
Serious Events(If Any):
Other Events(If Any):