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 @ 6:51 PM
Ignite Modification Date: 2025-12-25 @ 4:23 PM
NCT ID: NCT04240457
Description: None
Frequency Threshold: 5
Time Frame: 1 year
Study: NCT04240457
Study Brief: Safety and Efficacy of Corneal Crosslinking Using the PXL-Platinum 330 for Eyes With Corneal Ectatic Conditions
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pulsed, Accelerated Following riboflavin instillation, the eye was exposed to UVA pulsed light at 18mW/cm2 for 5 seconds, followed by 5 seconds off, repeating over 10 minutes of illumination. Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system.: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution. Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea. 0 None 0 7 1 7 View
Conventional Following riboflavin instillation, the eye was exposed to UVA continuous light at 9mW/cm2 for 10 minutes Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system.: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution. Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea. 0 None 0 4 0 4 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders None View