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: 2025-12-25 @ 4:29 AM
Ignite Modification Date: 2025-12-26 @ 3:32 AM
NCT ID: NCT02802020
Description: None
Frequency Threshold: 0
Time Frame: Adverse event information was collected from beginning of study participation until end of study, or approximately 12-15 months.
Study: NCT02802020
Study Brief: WallFlex Pancreatic Metal Stent for Pancreatic Duct Strictures
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
WallFlex FCSEMS Recipients The WallFlex™ Pancreatic RX Fully Covered Soft Stent System consists of a flexible delivery system preloaded with a self-expanding pancreatic metal stent. Patients who meet all eligibility criteria will receive the WallFlex Pancreatic stent for up to 6 months stent indwell and 6 months follow-up after stent removal. A patient is considered "enrolled" after signing the study-specific Informed Consent Form (ICF). Patients who sign the ICF but subsequently do not meet one or more of the selection criteria will be considered screen failures and excluded from the study. Pancreatic fully-covered self-expanding metal stent (FCSEMS): The WallFlex™ Pancreatic RX Fully Covered Soft Stent System consists of a flexible delivery system preloaded with a self-expanding pancreatic metal stent. 2 None 21 67 20 67 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Post-ERCP pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chronic pancreatitis exacerbation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Duodenal ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Elevated liver function tests SYSTEMATIC_ASSESSMENT Investigations None View
Ampullary occlusion of the bile duct SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Peripancreatic fluid collection SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Portal vein and SMV thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Fatal multiorgan failure from sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cholangitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Liver function test increased SYSTEMATIC_ASSESSMENT Investigations None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View