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 @ 10:46 PM
Ignite Modification Date: 2025-12-25 @ 8:16 PM
NCT ID: NCT03170869
Description: None
Frequency Threshold: 0
Time Frame: 6 months from the baseline procedure with the Surefire device
Study: NCT03170869
Study Brief: Bridge to Orthotopic Liver Transplantation (OLT) - Surefire Precision vs Endhole Embolization With DEBTACE
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DEB-TACE Procedure With Surefire Precision Infusion System The study duration for each patient is 24 months and includes a baseline visit, procedure visit and follow-up visits at 1 week, 1 month, 3 months, 6 months and every 3 months until liver transplant or death. The following evaluations/activities will be performed at baseline: Informed consent, history, physical exam, data collection of CT/ MRI within 1 month of the visit date, data collection of lab values and quality of life questionnaire. The treatment visit includes the DEB-TACE procedure with the Surefire Precision Infusion System. After the procedure, a Cone Beam CT of the liver will be performed to determine distribution and density of the beads in the tumor and adverse events monitoring. The following evaluations / activities will be performed during the follow-up period: physical exam, data collection of contrast enhanced CT/MRI to evaluate tumor response, data collection of lab values, adverse event monitoring and quality of life questionnaire. 0 None 2 11 11 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Infection NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Flow limiting dissection of the anterior right hepatic artery NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Chest pain during sleep NON_SYSTEMATIC_ASSESSMENT General disorders None View
Elevated AFP levels NON_SYSTEMATIC_ASSESSMENT General disorders None View
Occasional hot flashes NON_SYSTEMATIC_ASSESSMENT General disorders None View
Mild groin paint post re-treatment NON_SYSTEMATIC_ASSESSMENT General disorders None View
Elevated Hep C Quantitative PCR NON_SYSTEMATIC_ASSESSMENT General disorders None View
Muscle wasting NON_SYSTEMATIC_ASSESSMENT General disorders None View
Abdominal distention NON_SYSTEMATIC_ASSESSMENT General disorders None View
Edema NON_SYSTEMATIC_ASSESSMENT General disorders None View
Admission for infection NON_SYSTEMATIC_ASSESSMENT General disorders None View
Increased AFib NON_SYSTEMATIC_ASSESSMENT General disorders None View
Blood bilirubin increased NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypoalbuminemia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Elevated INR levels NON_SYSTEMATIC_ASSESSMENT General disorders None View
Headaches NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fever and chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Post embolization sydrome NON_SYSTEMATIC_ASSESSMENT General disorders None View
Difficulty with pain control NON_SYSTEMATIC_ASSESSMENT General disorders None View
Elevated AFP levels NON_SYSTEMATIC_ASSESSMENT General disorders None View
Elevated lactate whole blood venous levels NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cough and chest tightness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT General disorders None View
Encephalopathy NON_SYSTEMATIC_ASSESSMENT General disorders None View
Elevated ammonia levels NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hyperkalemia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT General disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT General disorders None View
Ascites NON_SYSTEMATIC_ASSESSMENT General disorders None View