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 @ 10:01 PM
Ignite Modification Date: 2025-12-25 @ 7:38 PM
NCT ID: NCT01047332
Description: None
Frequency Threshold: 5
Time Frame: From time of stent placement to participant death or lost to follow-up (up to 1302 days).
Study: NCT01047332
Study Brief: A Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile 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
Uncovered Wallstent Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type). None None 27 61 0 61 View
Partially Covered Wallstent Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type). None None 42 68 0 68 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Recurrent biliary obstruction None Hepatobiliary disorders None View
Stent migration None General disorders None View
Pancreatitis None Gastrointestinal disorders None View
Cholecystitis None Hepatobiliary disorders None View
Pain None General disorders None View
Line infection None Infections and infestations None View
Nausea None Gastrointestinal disorders None View
Dehydration None Metabolism and nutrition disorders None View
Deep vein thrombosis None Vascular disorders None View
Gastric outlet obstruction None Gastrointestinal disorders None View
Radiation gastritis None Gastrointestinal disorders None View
Pneumonia None Infections and infestations None View
Stroke None Nervous system disorders None View
Whipple resection None Surgical and medical procedures None View
Gastrointestinal bleeding None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Perforation None Gastrointestinal disorders None View
Diarrhea None Gastrointestinal disorders None View
Small bowel obstruction None Gastrointestinal disorders None View
Hernia None Gastrointestinal disorders None View
Liver abscess None Hepatobiliary disorders None View
Cholangitis without biliary obstruction None Hepatobiliary disorders None View
Cellulitis None Infections and infestations None View
Fever None Infections and infestations None View
Seizure None Nervous system disorders None View
Change in mental status None Nervous system disorders None View
Spinal surgery for cervical stenosis None Surgical and medical procedures None View
Pulmonary embolus None Vascular disorders None View
Myocardial infarction None Cardiac disorders None View
Pulmonary edema None Respiratory, thoracic and mediastinal disorders None View
Shortness of breath None Respiratory, thoracic and mediastinal disorders None View
Urinary obstruction None Renal and urinary disorders None View
Kidney stone None Renal and urinary disorders None View
Epistaxis None Vascular disorders None View
Other Events(If Any):