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 @ 2:33 PM
Ignite Modification Date: 2025-12-25 @ 1:05 PM
NCT ID: NCT00961259
Description: 54 subjects were enrolled in this study. Several subjects dropped out of the study prior to receiving all interventions. 53 subjects were administered Fenofibric Acid (1 x 35mg tablets), 54 subjects were administered Fenofibric Acid 105 mg (3 x 35 mg Tablets), and 53 subjects were administered Fenofibric Acid 105 mg (1 x 105 mg Tablets).
Frequency Threshold: 0
Time Frame: None
Study: NCT00961259
Study Brief: Fasted Pharmacokinetic and Bioequivalency Study of Fenofibric Acid
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fenofibric Acid 35 mg (1 x 35 mg Tablet), Treatment A Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours. None None 0 53 7 53 View
Fenofibric Acid 105 mg (3 x 35 mg Tablet), Treatment B Each subject received three (3) tablets of 35 mg fenofibric acid after an overnight fast of at least 10 hours. None None 0 54 4 54 View
Fenofibric Acid 105 mg (1 x 105 mg Tablet), Treatment C Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours. None None 0 53 5 53 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders None View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomach discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Vessel puncture site hematoma SYSTEMATIC_ASSESSMENT General disorders None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Orthodontic appliance complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View