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 @ 2:00 AM
Ignite Modification Date: 2025-12-26 @ 12:23 AM
NCT ID: NCT04134494
Description: Light spotting (bleeding from the area outside the vagina where the laser is used) Allergic reaction to topical anesthetic (numbing cream) Infection from the biopsy or the laser treatment
Frequency Threshold: 0
Time Frame: Baseline to six months
Study: NCT04134494
Study Brief: Laser Treatment for Vulvar Lichen Sclerosus
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intervention Women with biopsy-proven lichen sclerosus will be treated with the ProFractional hand piece using the sapphire plate stand-off (Sciton, Inc. Palo, Alto, CA). The laser energy is delivered in a scanning fractional pattern to ablate microchannels in tissue to allow faster healing. Treatment will be delivered in 3 sessions scheduled 4 weeks (+/- 1 week) apart Ablative Fractional 2940 nm Laser: • Treatment visit 1, month 0: On the first pass, the depth of the laser will be from 300 to 500 microns, or the thickness of 3 to 5 sheets of paper; the depth will be based on the biopsy that was used to diagnosis the lichen sclerosus. On the second pass, the depth will be 50 microns deeper than the first pass and the hand piece rotated 45˚. * Treatment visit 2, month 1: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚. * Treatment visit 3, month 2: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚. 0 None 0 13 0 13 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Light spotting NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Allergic reaction to topical anesthetic NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Infection from the biopsy or the laser treatment NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View