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 @ 4:58 AM
Ignite Modification Date: 2025-12-26 @ 3:58 AM
NCT ID: NCT04409418
Description: None
Frequency Threshold: 0
Time Frame: During hospital admission (beginning at enrollment) through 30 days post discharge, an average of 40 days
Study: NCT04409418
Study Brief: Blood Sampling Functionality of Extended Dwell Catheters
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Experimental Group If the patient is randomized to the experimental group (lower arm), the research staff will direct the insert to place the catheter into the forearm at least 10 cm away from the antecubital fossa. Extended dwell catheters: EDCs are generally placed using ultrasound for guidance and are commonly placed in any of 3 veins in the arm. They can be inserted above or below the antecubital fossa (the bend of your elbow). These catheters can be left for up to 30 days and don't fail as quickly when compared to peripheral IVs. 0 None 0 24 6 24 View
Control Group Control group (upper arm). If the patient is in the control group the research staff will direct the inserter to place the catheter into the upper arm vein at least 2 cm above the antecubital fossa. Extended dwell catheters: EDCs are generally placed using ultrasound for guidance and are commonly placed in any of 3 veins in the arm. They can be inserted above or below the antecubital fossa (the bend of your elbow). These catheters can be left for up to 30 days and don't fail as quickly when compared to peripheral IVs. 0 None 0 64 24 64 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Catheter occlusion NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Infiltration NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Catheter dislodgement NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Catheter leakage NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Superficial vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View