Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 11:56 PM
Ignite Modification Date: 2025-12-25 @ 9:53 PM
NCT ID: NCT00351351
Description: None
Frequency Threshold: 1
Time Frame: None
Study: NCT00351351
Study Brief: Trial Comparing Dual Probe Ultrasonic Lithotripsy to a Single Probe Ultrasonic Lithotripsy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cyberwand Cyberwand Cyberwand : FDA approved - dual probe intracorporeal lithotrite None None 0 34 10 34 View
Currently Available Lithotripsy Technology Currently available lithotripsy technology single probe ultrasonic : FDA-approved - single probe ultrasonic None None 0 36 15 36 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
fever SYSTEMATIC_ASSESSMENT Infections and infestations None View
hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
perinephric haematoma SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
persistent flank pain SYSTEMATIC_ASSESSMENT General disorders None View
pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
respiratory difficulty SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
discharged home with nephrostomy tube SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View