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 @ 4:55 AM
Ignite Modification Date: 2025-12-26 @ 3:55 AM
NCT ID: NCT04469218
Description: None
Frequency Threshold: 0
Time Frame: Patients evaluated and adverse events documents at every IV check from time of enrollment to time of discontinuation of IV therapy or up to 7 days, whichever occurs first
Study: NCT04469218
Study Brief: A Clinical Trial Using a New Medical Device to Evaluate Its Impact on IV Care and Clinical Complications
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SafeBreak Vascular Group Subjects in the SafeBreak Vascular group will have as near to identical treatment as possible to the control group with the exception that a SafeBreak Vascular device will be placed in the peripheral IV line. SafeBreak Vascular: SafeBreak Vascular is a breakaway connector that screws into peripheral IV lines using luer connectors on each end. The device is designed to separate when a harmful force is placed on an IV line. Upon separation, valves on each side of the device close. On the patient side of the device, the valve closes to prevent the loss of blood and on the IV pump side of the device, the valve closes to stop the flow of medication. The valve closing on the IV pump side of the line causes the pump's occlusion alarm to sound and notify nurses that the IV needs attention. The nurse is able to throw away the separated SafeBreak Vascular, install a new SafeBreak, and restart the patient's infusion without the negative cascade of events that can occur when a peripheral IV fails. 0 None 2 70 26 70 View
Control Group Subjects in the control group will receive the standard of care intervention for peripheral IVs at the study hospital. 0 None 2 69 33 69 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Unwitnessed Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blood Chemistry Abnormalities SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Dislodgement SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Infiltration SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Phlebitis VIP =/>2 SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Occlusion SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Device Crack/Leak SYSTEMATIC_ASSESSMENT Product Issues None View
IV Site Bleeding/Fluid Leakage SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Mental Status Change/Unwitnessed Fall SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Skin Reactions SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pains SYSTEMATIC_ASSESSMENT General disorders None View
Cardiovascular SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Nausea/Diarrhea SYSTEMATIC_ASSESSMENT General disorders None View
Elevated Temperature SYSTEMATIC_ASSESSMENT General disorders None View
Urinary Catheter Placed SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Post-op Complication SYSTEMATIC_ASSESSMENT General disorders None View