Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 9:09 PM
Ignite Modification Date: 2025-12-25 @ 6:59 PM
NCT ID: NCT01097304
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01097304
Study Brief: Ursodiol in Treating Patients With Barrett Esophagus and Low-Grade Dysplasia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment (Ursodiol) Patients receive ursodiol PO BID for 6 months in the absence of disease progression or unacceptable toxicity. Ursodiol: Given PO Laboratory Biomarker Analysis: Correlative studies None None 5 36 31 36 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypotension None Cardiac disorders None View
Ischemia/Infarction None Cardiac disorders None View
Atrial Fibrillation None Cardiac disorders None View
Enteritis None Gastrointestinal disorders None View
Barrett's esophagus with at least intramucosal carcinoma None Gastrointestinal disorders None View
Pancreatitis None Gastrointestinal disorders None View
Post surgical pain None Musculoskeletal and connective tissue disorders None View
CNS cerebrovascular ischemia None Nervous system disorders None View
Altered mental status None Nervous system disorders None View
Chest/Thorax pain None Cardiac disorders None View
Renal failure None Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
hypertension None Cardiac disorders None View
Fatigue None General disorders None View
Fever None General disorders None View
Joint pain None Musculoskeletal and connective tissue disorders None View
Stomach pain None Gastrointestinal disorders None View
Phlebitis None Vascular disorders None View
Weight loss None Investigations None View
Pruritus None Skin and subcutaneous tissue disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Colitis None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Diarrhea None Gastrointestinal disorders None View
Distention/Bloating None Gastrointestinal disorders None View
Flatulence None Gastrointestinal disorders None View
Heartburn None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Phytobezoar None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Upper airway infection None Infections and infestations None View
Hyponatremia None Metabolism and nutrition disorders None View
Dizziness None Nervous system disorders None View
Abdomen pain None Gastrointestinal disorders None View
Back pain None Musculoskeletal and connective tissue disorders None View
Headache None Nervous system disorders None View