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: 2025-12-25 @ 12:41 AM
Ignite Modification Date: 2025-12-25 @ 10:52 PM
NCT ID: NCT00587067
Description: None
Frequency Threshold: 0
Time Frame: 5 years
Study: NCT00587067
Study Brief: A Phase II Study of Continuous Hepatic Arterial Infusion With Floxuridine (FUDR) and Dexamethasone (DEX) in Patients With Unresectable Primary Hepatic Malignancy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Floxuridine + Dexamethasone FLOXURIDINE: \[0.16\* mg/kg/day X 30 ml\] / pump flow rate \* If the patient is \>25% above ideal body weight, the dose of FUDR will be calculated from an average of the patients actual and ideal body weights. For example, for a patient who is 5ft. 10 inches and weighs 100kg: Ideal Body Weight (kg) = 50 + (2.3 X height in inches over 5 feet) = 50 + (2.3 X 10) = 73 Weight Used for dose calculation = (100 + 73)/2 = 86.5 Therefore, FUDR Dose will be = (0.16 X 86.5 X 30)/Flow Rate If no dose modification due to toxicity is required, the dosages given above (adjusted for changes in weight and pump flow rate) will be repeated on Day 1 of Week 1 of Cycle 2 and all subsequent cycles. 33 None 5 34 5 34 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bilirubin Increased SYSTEMATIC_ASSESSMENT Investigations None View
Melena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GI, other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hepatic, other SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Pain, other SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Increased bilirubin SYSTEMATIC_ASSESSMENT Investigations None View
Headache/Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Delerium SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View