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 @ 9:24 PM
Ignite Modification Date: 2025-12-25 @ 7:10 PM
NCT ID: NCT05228132
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected from Index Procedure to the 1-month Endpoint or until study termination which on average was 42 days, a minimum of 17 days, and a maximum of 77 days.
Study: NCT05228132
Study Brief: The Pristine Post-Market Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pristine™ Long-Term Hemodialysis Catheter The Pristine™ Long-Term Hemodialysis Catheter is a chronic hemodialysis catheter consisting of a dual lumen radiopaque shaft with a pre-formed split tip, which enables long-term vascular access for hemodialysis. The device is intended to be used in patients suffering from chronic kidney disease. The Pristine™ Catheter will be placed according to the Instructions for Use (IFU). Pristine™ Long-Term Hemodialysis Catheter: Placement of the Pristine™ Long-Term Hemodialysis Catheter Placement. 0 None 3 7 2 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Not Device Related-Septic Shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Device Related-Thrombosis in device NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Device Related-Thrombosis in device NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Procedural pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View