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 @ 4:34 PM
Ignite Modification Date: 2025-12-25 @ 2:25 PM
NCT ID: NCT03024866
Description: All additional adverse events that were collected have been reported. The only adverse events reported were all skin toxicities from CTCAE.
Frequency Threshold: 0
Time Frame: Patients have been followed for 2.6 to 4.3 years after EBT, and 2.3 to 5 years following MMS.
Study: NCT03024866
Study Brief: Comparison of eBX and Mohs Surgery for Treatment of Early-stage Non-melanoma Skin Cancer a Matched Pair Cohort 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
Mohs Surgery Previously completed treatment for non-melanoma skin cancer using Mohs Surgery 0 None 0 181 79 181 View
Electronic Brachytherapy Previously completed treatment for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System 0 None 0 188 107 188 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Late toxicities SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View