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 @ 1:39 PM
Ignite Modification Date: 2025-12-25 @ 12:36 PM
NCT ID: NCT04226495
Description: AEs and SAEs will be captured on a source document page. AEs and SAEs will be reported to the PI within 24 hrs of notice of occurrence. AEs and SAEs will be reviewed by PI for severity and relationship. Any reportable AEs will be reported to the IRB within 5 business days, and SAEs will be reported to Institutional Review Board within 24 hrs of PI becoming aware of occurrence. PI will determined what follow up is needed for each event.
Frequency Threshold: 5
Time Frame: Procedure end time to discharge from hospital, an average of 4 days.
Study: NCT04226495
Study Brief: Sufentanil Infusion vs Sufentanil Bolus
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sufentanil Infusion Sufentanil Infusion: Intra-operative sufentanil infusion 0 None 1 33 5 33 View
Sufentanil Bolus Sufentanil Bolus: Intra-operative sufentanil bolus 0 None 1 31 4 31 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute left MCA stroke SYSTEMATIC_ASSESSMENT Vascular disorders None View
Emergent OR procedure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View