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 @ 1:04 PM
Ignite Modification Date: 2025-12-25 @ 12:20 PM
NCT ID: NCT02875561
Description: None
Frequency Threshold: 0
Time Frame: 12 months
Study: NCT02875561
Study Brief: Ultrasonic Aspiration Versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sonopet Ultrasonic Aspirator Treatment of VIN dysplasia with sonopet ultrasonic aspirator: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation Sonopet Ultrasonic Aspirator: To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation 0 None 0 19 12 19 View
CO2 Laser Ablation Treatment of VIN dysplasia with CO2 Laser Ablation: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation CO2 Laser Ablation: To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation 0 None 0 28 18 28 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
cellulitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
discomfort SYSTEMATIC_ASSESSMENT General disorders None View
pain SYSTEMATIC_ASSESSMENT General disorders None View
vaginal bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
anal pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
tenderness SYSTEMATIC_ASSESSMENT General disorders None View
infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
irritation SYSTEMATIC_ASSESSMENT General disorders None View
yeast infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
itching SYSTEMATIC_ASSESSMENT General disorders None View
soreness at site SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View