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 @ 4:52 PM
Ignite Modification Date: 2025-12-25 @ 2:35 PM
NCT ID: NCT03294850
Description: None
Frequency Threshold: 0
Time Frame: 2.22 years
Study: NCT03294850
Study Brief: Biomarkers of Liver Pathology in Patients With Presumed Non-Alcoholic Steatohepatitis Following Bariatric Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
NASH Group These are individuals that have been identified as having NASH by MRE. Confirmation with liver biopsy required for continuation in the longitudinal study. Bariatric surgery: Subjects enrolling in the study who are undergoing bariatric surgery as part of their medical care will be studied HepQuant SHUNT Dual Cholate Liver Diagnostic Kit: For the experimental group, the device will be used to monitor the effect of bariatric surgery on liver function. For the active comparator group, the device will be used for the assessment of baseline liver function. 0 None 0 4 2 4 View
Non-NASH (NAFLD or Normal) Group These are individuals that do not have NASH. They either have normal liver physiology or only have evidence of hepatic steatosis. This group will be studied up until the day of their bariatric surgery and will serve as a comparator population with respect to baseline measurements. Bariatric surgery: Subjects enrolling in the study who are undergoing bariatric surgery as part of their medical care will be studied HepQuant SHUNT Dual Cholate Liver Diagnostic Kit: For the experimental group, the device will be used to monitor the effect of bariatric surgery on liver function. For the active comparator group, the device will be used for the assessment of baseline liver function. 0 None 0 10 9 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ear Infection SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Bruising, tenderness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cyst in pituitaty SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Gas Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
H. Pylori Infection SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Inactive mild gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lower Leg Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Migraine SYSTEMATIC_ASSESSMENT General disorders None View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Right Arm Tenderness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Shingles SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinus Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Urinary Tract Infections SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vitamin D Defficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Worsening Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View