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 @ 8:00 PM
Ignite Modification Date: 2025-12-25 @ 5:33 PM
NCT ID: NCT00600704
Description: None
Frequency Threshold: 3
Time Frame: None
Study: NCT00600704
Study Brief: Impact of Fluid Restriction Policy in Reducing the Use of Red Cells in Cardiac Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
FREE FLUIDS Free fluid infusion unless Hb\< 6g/dl(allogenic blood use) None None 18 92 2 92 View
RESTRICTED FLUIDS Infusion of Hes 130/0.4 up to 500 ml None None 20 100 2 100 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
myocardial infraction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
persistent significant arrythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
low output syndrome SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
persistent neurological dysfunction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
lower extremity ischemia NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
reoperation for bleeding NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View