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 @ 4:58 PM
Ignite Modification Date: 2025-12-25 @ 2:39 PM
NCT ID: NCT00781950
Description: The adverse events were recorded by the research nurse upon follow-up visits.
Frequency Threshold: 5
Time Frame: None
Study: NCT00781950
Study Brief: Effects of Dietary Flaxseed on Symptoms of Cardiovascular Disease in Patients With Peripheral Arterial Disease
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 Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat, wheat bran, and mixed dietary oils to replace the flaxseed daily for one year. None None 9 52 0 52 View
Flaxseed Randomized, Blinded group of patients that will be given food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing 30 g of milled flaxseed daily for one year Flaxseed: 30 grams of milled flaxseed per day in food products or on its own. None None 15 58 3 58 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Increased Numbess in Extremities SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ulcerative Cellulitis SYSTEMATIC_ASSESSMENT General disorders None View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Stroke SYSTEMATIC_ASSESSMENT General disorders None View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Increased Claudication SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Iliac Artery Stenosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Rest Pain in Limbs SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View