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 @ 7:10 PM
Ignite Modification Date: 2025-12-25 @ 4:43 PM
NCT ID: NCT02106403
Description: None
Frequency Threshold: 1
Time Frame: AEs were collected from the start of the investigational product, and until last visit (7 days following last administration of the investigational product).
Study: NCT02106403
Study Brief: A Study to Evaluate the Cooling Sensation and Consumer Liking of a Skin Disinfectant Spray
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Prototype Disinfectant Spray Formulation 0.13% w/w BAC and 1% MGA. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound. None None 0 50 1 50 View
Reference Product 0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound. None None 0 50 1 50 View
Negative Control 0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound. None None 0 50 1 50 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Itch in all three wounds(Wound Complication) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View