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: 2025-12-25 @ 12:36 AM
Ignite Modification Date: 2025-12-25 @ 10:46 PM
NCT ID: NCT00174967
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00174967
Study Brief: Dose-Response, Safety and Efficacy of 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. None None 0 37 18 37 View
Febuxostat 120 mg QD Febuxostat 120 mg, orally, once daily. None None 2 38 16 38 View
Placebo QD Placebo, orally, once daily None None 0 38 17 38 View
Febuxostat 80 mg QD Febuxostat 80 mg, orally, once daily. None None 1 40 19 40 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Suicide Attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders COSTART View
Delirium SYSTEMATIC_ASSESSMENT Nervous system disorders COSTART View
Guillian Barre Syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders COSTART View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders COSTART View
Back Pain SYSTEMATIC_ASSESSMENT General disorders COSTART View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Pain SYSTEMATIC_ASSESSMENT General disorders COSTART View
Accidental Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications COSTART View
Back Pain SYSTEMATIC_ASSESSMENT General disorders COSTART View
Flu Syndrome SYSTEMATIC_ASSESSMENT General disorders COSTART View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders COSTART View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations COSTART View
Pain SYSTEMATIC_ASSESSMENT General disorders COSTART View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART View
Increased Appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders COSTART View
Liver Function Tests Abnormal SYSTEMATIC_ASSESSMENT Investigations COSTART View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders COSTART View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders COSTART View
Pharyngitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders COSTART View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders COSTART View