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 @ 4:44 PM
Ignite Modification Date: 2025-12-25 @ 2:32 PM
NCT ID: NCT04688450
Description: Adverse events (AEs) were determined systematically by a real-time technical observer; nurse-subject surveys; and the software logs. Expected AEs in a population of ICU patients on vasopressors included all sustained hypotension episodes; tachyarrhythmias (HR \> 150 bpm) or bradyarrhythmias (HR \< 50 bpm) that persist for more than ten minutes; need for chest compressions or defibrillation; or any unscheduled bedside response by the ICU care team involving more than the patient's primary nurse.
Frequency Threshold: 0
Time Frame: 4-8 hours (duration of investigational protocol)
Study: NCT04688450
Study Brief: BP Management System User Acceptance Testing
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intervention Group The investigational system will be evaluated for safety and user acceptance in 20 patient-subjects and associated nurse-subjects VIGORIS Blood Pressure Management Clinical Decision Support System: Software system to optimize tight blood pressure management during vasopressor infusion 0 None 9 20 1 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sustained hypotensive event SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Multi-clinician response SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Unable to electronically communicate with GE monitor SYSTEMATIC_ASSESSMENT Investigations None View