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 @ 9:10 PM
NCT ID: NCT04253756
Description: When the return rate is out of the SOC parameters the SOC apheresis equipment (Optia or Cellex) will alarm. If the alarm sounds 3 times the RN will decrease inlet rate by 5 ml/sec until the minimum threshold is reached (if needed), which is 50 ml/sec for plasma exchange and 35 ml/sec for RBC exchange and 20 ml/sec for photopheresis. If the alarm continues to when the minimum threshold is reached the catheter will be replaced with the SOC 18-gauge catheter.
Frequency Threshold: 0
Time Frame: 12 months
Study: NCT04253756
Study Brief: A Randomized Trial Examining Plasma Exchange Using the Becton Dickinson (BD) Catheter In an Outpatient Apheresis Unit
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
18-gauge Autogard Catheter Standard of care 0 None 0 13 0 13 View
20-gauge BD Nexiva Diffusics Intervention 20-gauge BD Nexiva Diffusics: The BD Nexiva Diffusics catheters are suitable for use with power injectors when a direct connection is made. 0 None 0 13 0 13 View
Serious Events(If Any):
Other Events(If Any):