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 @ 12:47 PM
Ignite Modification Date: 2025-12-25 @ 12:15 PM
NCT ID: NCT00696761
Description: None
Frequency Threshold: 3.9
Time Frame: None
Study: NCT00696761
Study Brief: The Long Term Effects of Alfuzosin(Xatral XL) in Lower Urinary Tract Symptoms(LUTS)/BPH Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group 3 BOOI\<20, BCI≥ 100) alfuzosin : 10mg, once daily, 12months None None 0 41 2 41 View
Group 4 BOOI\<20, BCI\<100 alfuzosin : 10mg, once daily, 12 months None None 0 54 2 54 View
group1 BOOI≥ 20, BCI≥ 100 alfuzosin : 10mg, once daily, 12months None None 0 61 2 61 View
group2 BOOI≥ 20, BCI\<100 alfuzosin : 10mg, once daily, 12months None None 0 76 3 76 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
dizziness SYSTEMATIC_ASSESSMENT Vascular disorders None View