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 @ 3:54 AM
Ignite Modification Date: 2025-12-26 @ 2:43 AM
NCT ID: NCT00103402
Description: None
Frequency Threshold: 5
Time Frame: 12 weeks
Study: NCT00103402
Study Brief: Trial to Compare Alfuzosin Versus Placebo in the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Alfuzosin 10 mg of alfuzosin once daily for 12 weeks 0 None 1 138 40 138 View
Placebo 10 mg of an identical-looking placebo once daily for 12 weeks 0 None 2 134 46 134 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Spontaneous pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Traumatic head laceration SYSTEMATIC_ASSESSMENT Investigations None View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constitutional events SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal events SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neurologic events SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pain in any body system SYSTEMATIC_ASSESSMENT General disorders None View