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 @ 6:25 PM
Ignite Modification Date: 2025-12-25 @ 3:55 PM
NCT ID: NCT06241768
Description: No adverse events were collected systematically for this study. The study intervention was a digital health program (a decision aid) for routine colorectal cancer screening as recommended by United States Preventive Services Task Force guidelines. Therefore, no adverse events were expected or collected.
Frequency Threshold: 0
Time Frame: No adverse events were collected systematically for this study. The study intervention was a digital health program (a decision aid) for routine colorectal cancer screening as recommended by United States Preventive Services Task Force guidelines. Therefore, no adverse events were expected or collected.
Study: NCT06241768
Study Brief: Feasibility of a Colorectal Cancer Screening Web App in Primary Care Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Text Message 3 Version 3 of the text message invitation to use the cloud-based colorectal cancer screening program mPATH-CRC Web app: Cloud-based web application that informs individuals of colorectal cancer screening and helps them receive screening 0 None 0 0 0 0 View
Text Message 4 Version 4 of the text message invitation to use the cloud-based colorectal cancer screening program mPATH-CRC Web app: Cloud-based web application that informs individuals of colorectal cancer screening and helps them receive screening 0 None 0 0 0 0 View
Text Message 1 Version 1 of the text message invitation to use the cloud-based colorectal cancer screening program mPATH-CRC Web app: Cloud-based web application that informs individuals of colorectal cancer screening and helps them receive screening 0 None 0 0 0 0 View
Text Message 2 Version 2 of the text message invitation to use the cloud-based colorectal cancer screening program mPATH-CRC Web app: Cloud-based web application that informs individuals of colorectal cancer screening and helps them receive screening 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):