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 @ 9:20 PM
Ignite Modification Date: 2025-12-25 @ 7:07 PM
NCT ID: NCT04158804
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data was collected starting at enrollment day until 30 days after enrollment.
Study: NCT04158804
Study Brief: PROcalcitonin Impact on Antibiotic Reduction, adverSe Events and AVoidable healthcarE Costs (ProSAVE): A RCT
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard of Care (SOC) PCT results were hidden from the medical record and no ASP recommendation given. 19 None 76 357 0 357 View
PCT/ASP PCT results were posted in the medical record and ASP emailed recommendation to the medical team. 17 None 81 343 0 343 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death NON_SYSTEMATIC_ASSESSMENT General disorders None View
Septic Shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Mechanical Ventilation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dialysis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Empyema NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Readmission NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):