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 @ 7:32 PM
Ignite Modification Date: 2025-12-25 @ 5:14 PM
NCT ID: NCT04196803
Description: The definition of adverse event and/or serious adverse event is from the clinicaltrials.gov Definitions. We conducted safety and compliance calls to collect adverse event data.
Frequency Threshold: 0
Time Frame: In the 12 weeks trial, we conducted safety and compliance calls to collect adverse event data.
Study: NCT04196803
Study Brief: Ancillary Study of Methylation Biomarkers in a Randomized Controlled Trial of a Personalized Prevention of Colorectal Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Participants were assigned to placebo group Placebo: Oral administration of identical-appearing placebo daily for 12 weeks 0 None 0 126 3 126 View
Magnesium Treatment Participants were assigned to magnesium glycinate Magnesium glycinate: Oral administration of magnesium glycinate daily for 12 weeks 0 None 0 124 4 124 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bleeding after the rectal biopsy procedure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Feel sick SYSTEMATIC_ASSESSMENT General disorders None View
Arthritic pain in fingers SYSTEMATIC_ASSESSMENT General disorders None View
Weight gain SYSTEMATIC_ASSESSMENT General disorders None View
Interaction with blood pressure medication SYSTEMATIC_ASSESSMENT Vascular disorders None View