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 @ 11:24 PM
Ignite Modification Date: 2025-12-25 @ 9:09 PM
NCT ID: NCT00410956
Description: None
Frequency Threshold: 0
Time Frame: Up to 36 months
Study: NCT00410956
Study Brief: Floxuridine and Dexamethasone as a Hepatic Arterial Infusion and Bevacizumab in Treating Patients With Primary Liver Cancer That Cannot be Removed by 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
UNRESECTABLE PRIMARY HEPATIC MALIGNANCY All patients enrolled in the study will receive HAI FUDR (0.16 mg/kg X pump volume / pump flow rate), Dexamethasone (1 mg/m2/day) and IV Bevacizumab at 5mg/kg. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days post surgical placement of HAI pump; patients will receive their first treatment with Bevacizumab no sooner than 28 days post surgical placement of HAI pump. bevacizumab dexamethasone floxuridine protein expression analysis flow cytometry immunoenzyme technique immunohistochemistry staining method immunologic technique laboratory biomarker analysis dynamic contrast-enhanced magnetic resonance imaging 21 None 12 22 17 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pain, headache, nausea SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Mucosal tear, duodenal bulb SYSTEMATIC_ASSESSMENT Eye disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Portal hypertension, esophageal varices SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
PV thrombosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Myocardial infarct SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Allergic reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Ileitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Liver function derangement SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View