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: 2025-12-25 @ 1:13 AM
Ignite Modification Date: 2025-12-25 @ 11:23 PM
NCT ID: NCT04123093
Description: A questionnaire about adverse events was administered to each patient. The questionnaire asked about adverse reactions related to the skin and application site, systemic reactions, infections, and allergic reactions.
Frequency Threshold: 0
Time Frame: Adverse event data was collected up to 4 weeks for Healthy Volunteers and up to 13 months for Wound Care participants.
Study: NCT04123093
Study Brief: Safety and Efficacy of the Noxsano Wound Care Bandage
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Healthy Volunteers Healthy volunteers with no skin wounds and who are not taking any prescription medications. 0 None 0 10 7 10 View
Wound Care Subjects with a lower extremity ulceration attributed to diabetes and/or arterial insufficiency. 0 None 1 2 2 2 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
skin flaking SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
itchy skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
dry dkin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
red skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
swollen skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
bruise SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
skin discoloration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
skin darkening SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
pressure sores SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View