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 @ 12:22 PM
Ignite Modification Date: 2025-12-25 @ 12:03 PM
NCT ID: NCT01786161
Description: Nephrotoxicity was defined as an increase in serum creatinine (SCr) by 0.5 mg/dL or at least a 50% increase from baseline over 2 consecutive SCr values.
Frequency Threshold: 0
Time Frame: Adverse event data were collected while subjects are receiving vancomycin therapy.
Study: NCT01786161
Study Brief: Prospective Evaluation of a Vancomycin Nomogram With a Continuous Infusion of Vancomycin for Surgical ICU Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Vancomycin Continous Infusion continuous 24 hours intravenous infusion Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion None None 0 22 1 22 View
Intermittent Infusion infusion rate 1000mg/hr Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr None None 0 22 4 22 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nephrotoxicity SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View