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 @ 4:12 AM
Ignite Modification Date: 2025-12-26 @ 3:11 AM
NCT ID: NCT01274520
Description: Serious Adverse Event (SAE) is defined as any clinically significant event which required a hospitalization admission during the subject's participation in the trial. Only SAEs were reported for the purposes of data collection and data analysis in this study.
Frequency Threshold: 5
Time Frame: 1 year
Study: NCT01274520
Study Brief: Hypothermic Machine Preservation-Phase 2
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Matched Control Group This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored ECD grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository. 0 None 11 25 0 25 View
Experimental: Hypothermic Machine Perfusion Group Group 24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement. 6 None 6 24 0 24 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Events Requiring Hospitalization SYSTEMATIC_ASSESSMENT Hepatobiliary disorders Serious View
Other Events(If Any):