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 @ 4:49 PM
Ignite Modification Date: 2025-12-25 @ 2:34 PM
NCT ID: NCT02002650
Description: Adverse events related to ERCP or indomethacin include bleeding, perforation, biliary infection, cardiovascular or renal adverse events and other adverse events.
Frequency Threshold: 0.01
Time Frame: 30 days
Study: NCT02002650
Study Brief: Rectal Indomethacin to Prevent Post-ERCP Pancreatitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Post-ERCP Group Post-ERCP rectal Indomethacin in high-risk patients. Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not. None None 15 1303 33 1303 View
Pre-ERCP Group Pre-ERCP rectal Indomethacin in all patients. Pre-ERCP rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients. None None 15 1297 26 1297 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Moderate to severe bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Bleeding View
Moderate to severe biliary infection SYSTEMATIC_ASSESSMENT Infections and infestations Biliary infection View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mild bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Mild bleeding View
Mild perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Mild perforation View
Pulmonary infection SYSTEMATIC_ASSESSMENT Infections and infestations Pulmonary infection View
Incomplete bowel obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Incomplete bowel obs View
Mild biliary infection SYSTEMATIC_ASSESSMENT Infections and infestations Miliary infection View