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 @ 11:33 PM
Ignite Modification Date: 2025-12-25 @ 9:22 PM
NCT ID: NCT00960856
Description: 37 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 35 subjects were administered Fenofibric Acid 105 mg tablets with a low fat meal, high fat meal and in a fasted state. 36 subjects were administered Fenofibric Acid 105 mg tablets with a standard meal.
Frequency Threshold: 0
Time Frame: None
Study: NCT00960856
Study Brief: Four Arm Food Effect Study of Fenofibric Acid Tablets
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Low-Fat Meal - Treatment A Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a low-fat breakfast. None None 0 35 9 35 View
Standard Meal - Treatment B Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a standard breakfast. None None 0 36 2 36 View
High-fat, High-calorie Meal - Treatment C Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a high-fat, high-calorie breakfast. None None 0 35 4 35 View
Fasted - Treatment D Each subject received one tablet of 105 mg fenofibric acid following an overnight fast of at least 10 hours. None None 0 35 4 35 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vessel puncture site hematoma SYSTEMATIC_ASSESSMENT General disorders None View
Vessel puncture site pain SYSTEMATIC_ASSESSMENT General disorders None View
Vessel puncture site reaction SYSTEMATIC_ASSESSMENT General disorders None View
Blood creatine kinase increased SYSTEMATIC_ASSESSMENT Investigations None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View