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 @ 11:10 PM
Ignite Modification Date: 2025-12-25 @ 8:44 PM
NCT ID: NCT02082769
Description: None
Frequency Threshold: 1
Time Frame: None
Study: NCT02082769
Study Brief: Safety and Efficacy of Oral Febuxostat in Subjects With Gout
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Febuxostat 40 mg QD Febuxostat 40 mg, orally, once daily for up to 24 weeks Febuxostat None None 0 168 45 168 View
Febuxostat 80 mg QD Febuxostat 80 mg, orally, once daily for up to 24 weeks Febuxostat None None 1 168 46 168 View
Allopurinol 100mg QD Allopurinol 100mg, orally, three times daily for up to 24 weeks Allopurinol None None 0 168 41 168 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Liver function test abnormalities SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Renal function test abnormalities SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Abnormal electrocardiogram SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abnormal urine protein SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Drug allergy SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Gastrointestinal disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Others SYSTEMATIC_ASSESSMENT General disorders None View