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 @ 3:44 PM
Ignite Modification Date: 2025-12-25 @ 1:52 PM
NCT ID: NCT03264092
Description: Adverse events evaluated in this study were: bleeding, bowel perforation and hemodynamic instability. The definitions of these adverse events are similar to the ones established by clinicaltrials.gov
Frequency Threshold: 0
Time Frame: 2 hours
Study: NCT03264092
Study Brief: Comparison of Three Tissue Acquiring Techniques During EUS Guided Biopsies of Solid Tumors.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Wet Suction This arm included all the patients that got an endoscopic ultrasound guided fine needle biopsy done with the wet suction technique=17 subjects 0 None 0 17 0 17 View
Dry Suction This arm included all the patients that got and endoscopic ultrasound guided fine needle biopsy done with the dry suction technique=20 subjects 0 None 0 20 3 20 View
Slow Pull This arm included all the patients that got an endoscopic ultrasound guided fine needle biopsy done with the slow pull technique=18 subjects \\ 0 None 0 18 0 18 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bleeding NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View