NCT03392935 · ADVERSE EVENTS

Adverse events

Efficacy of 1540 Nanometer Erbium Glass Laser to Improve Benign Dermatofibromas · Source last updated 2023-05-08

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Adverse events were collected from baseline to week 12.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
All Subjects All subjects will be treated with the laser at week 0 and week 4. Only assessors will be blinded and rate the dermatofibromas in photographs, they will not know which photos were taken pre-treatment vs. post-treatment to determine efficacy. 1540 nanometer Erbium glass laser: Subjects will receive laser treatment by dermatologist at week 0 and week 4.	0 / 37	37 / 37	0 / 37

Group identifiers: EG000: All Subjects

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Transient expected redness at the site of laser applicaiton, resolving within 3 days of treatment without sequela. .
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
37
num At Risk
37
num Events
87
term
Transient Erythema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Transient expected swelling at site of laser application, resolving within 3 days of treatment without sequela.
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
37
num At Risk
37
num Events
87
term
Transient Edema

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
37
description
All subjects will be treated with the laser at week 0 and week 4. Only assessors will be blinded and rate the dermatofibromas in photographs, they will not know which photos were taken pre-treatment vs. post-treatment to determine efficacy. 1540 nanometer Erbium glass laser: Subjects will receive laser treatment by dermatologist at week 0 and week 4.
id
EG000
other Num Affected
37
other Num At Risk
37
serious Num Affected
0
serious Num At Risk
37
title
All Subjects

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Transient expected redness at the site of laser applicaiton, resolving within 3 days of treatment without sequela. .
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
37
num At Risk
37
num Events
87
term
Transient Erythema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Transient expected swelling at site of laser application, resolving within 3 days of treatment without sequela.
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
37
num At Risk
37
num Events
87
term
Transient Edema

time Frame

Adverse events were collected from baseline to week 12.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice