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 @ 2:19 AM
Ignite Modification Date: 2025-12-26 @ 12:50 AM
NCT ID: NCT01863134
Description: Death up to 12 Months
Frequency Threshold: 1.4
Time Frame: 12 Months
Study: NCT01863134
Study Brief: Clinical Effects of Eptifibatide Administration in High Risk Patients Presenting With Non-ST Segment Elevation Acute Coronary Syndrome (NSTE-ACS) Requiring Urgent Coronary Artery Bypass Graft Surgery in Short- and Long-Term Follow-up
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Eptifibatide Patients were given a bolus of eptifibatide (Integrillin; 180µg/kg of body weight) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery). None None 2 72 3 72 View
Placebo Patients were given placebo infusion (0,9% Natrium Chloride) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery). None None 7 68 9 68 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death up to 12 Months None General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pulmonary infection None Infections and infestations None View
Delirium None Nervous system disorders None View