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 @ 9:24 PM
Ignite Modification Date: 2025-12-25 @ 7:10 PM
NCT ID: NCT04957732
Description: The protocol did not outline procedures to capture AEs, as the primary purpose was to assess the primary and secondary endpoints. Therefore, AEs were assessed as a post-hoc analysis. Worsening of any symptoms from baseline were considered AEs. The categories of AEs included pain, vomiting, exudation, depth, erythema, swelling, induration, fluctuance, warmth, \& signs of active infection. All cause mortality and serious adverse events were not collected nor assessed.
Frequency Threshold: 5
Time Frame: Adverse events (AEs) were reviewed, beginning at baseline, up to study completion 48 hours later.
Study: NCT04957732
Study Brief: The Effect of Wound Irrigation With Irrisept on Abscess Healing (Irrisept UF Study)
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) For subjects randomized to SoC, normal saline was used. Assessments were made anytime after consent, while the study participated in the trial. 0 None 0 0 12 18 View
Irrisept For subjects randomized to the investigational group, Irrisept was used. Assessments were made anytime after consent, while the study participated in the trial. 0 None 0 0 6 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
All Worsening Symptoms NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pain NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Erythema NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Swelling NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Exudation NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Depth NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Induration NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fluctuance NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Active Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Warmth NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Redness NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View