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 @ 7:43 PM
Ignite Modification Date: 2025-12-25 @ 5:21 PM
NCT ID: NCT05429203
Description: None
Frequency Threshold: 5
Time Frame: 3 months
Study: NCT05429203
Study Brief: Comparison of Duodenoscope With Single-use Distal Cover and the Conventional Reusable Duodenoscope
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Duodenoscope With Disposable Distal End Caps Patients will undergo ERCP using a duodenoscope with a single-use distal cover. 1 None 8 159 8 159 View
Conventional Reusable Duodenoscope Patients will undergo ERCP using a conventional duodenoscope. 0 None 9 160 8 160 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Post ERCP pancreatitis (PEP) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Post-sphincterotomy bleeding SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Perforation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Liver failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdomen pain (without post-ERCP pancreatitis) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View