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 @ 12:27 AM
Ignite Modification Date: 2025-12-25 @ 10:32 PM
NCT ID: NCT03509467
Description: Adverse Events were not collected
Frequency Threshold: 0
Time Frame: Adverse Events were not collected
Study: NCT03509467
Study Brief: Using MC1R Genotype to Impact Melanoma Risk Behavior
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MC1R Average Risk - Intervention- Non-Hispanic White Population Participants in the average risk precision prevention arm (intervention) received mailed materials containing information on: (1) melanoma and skin cancer; (2) genetic risk for melanoma; (3) MC1R and its role in developing melanoma, their MC1R risk group, and interpretation of risk information; and (4) melanoma prevention behaviors in the context of genetic risk. 0 None 0 0 0 0 View
MC1R Higher Risk- Control - Non-Hispanic White Population Post determination of MC1R Genotypes, participants in the higher risk standard arm (control) received mailed materials containing information on (1) melanoma and skin cancer; and (2) melanoma prevention behaviors recommended by the American Academy of Dermatology. All participants received information on sun protection behaviors targeted at children. 0 None 0 0 0 0 View
MC1R Higher Risk - Intervention- Non-Hispanic White Population Participants in the higher risk precision prevention arm (intervention) received mailed materials containing information on: (1) melanoma and skin cancer; (2) genetic risk for melanoma; (3) MC1R and its role in developing melanoma, their MC1R risk group, and interpretation of risk information; and (4) melanoma prevention behaviors in the context of genetic risk. 0 None 0 0 0 0 View
MC1R Average Risk - Intervention- Hispanic Population Participants in the average risk precision prevention arm (Intervention) received mailed materials containing information on: (1) melanoma and skin cancer; (2) genetic risk for melanoma; (3) MC1R and its role in developing melanoma, their MC1R risk group, and interpretation of risk information; and (4) melanoma prevention behaviors in the context of genetic risk. 0 None 0 0 0 0 View
MC1R Higher Risk - Intervention- Hispanic Population Participants in the higher risk precision prevention arm (intervention) received mailed materials containing information on: (1) melanoma and skin cancer; (2) genetic risk for melanoma; (3) MC1R and its role in developing melanoma, their MC1R risk group, and interpretation of risk information; and (4) melanoma prevention behaviors in the context of genetic risk. 0 None 0 0 0 0 View
MC1R Average Risk- Control- Non-Hispanic White Population Post determination of MC1R Genotypes, participants in the average risk standard arm (control) received mailed materials containing information on (1) melanoma and skin cancer; and (2) melanoma prevention behaviors recommended by the American Academy of Dermatology. All participants received information on sun protection behaviors targeted at children. 0 None 0 0 0 0 View
MC1R Average Risk- Control- Hispanic Population Post determination of MC1R Genotypes, participants in the average risk standard arm (Control) received mailed materials containing information on (1) melanoma and skin cancer; and (2) melanoma prevention behaviors recommended by the American Academy of Dermatology. All participants received information on sun protection behaviors targeted at children. 0 None 0 0 0 0 View
MC1R Higher Risk- Control - Hispanic Population Post determination of MC1R Genotypes, participants in the higher risk standard arm (Control) received mailed materials containing information on (1) melanoma and skin cancer; and (2) melanoma prevention behaviors recommended by the American Academy of Dermatology. All participants received information on sun protection behaviors targeted at children. 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):