NCT02875561 · ADVERSE EVENTS

Adverse events

Ultrasonic Aspiration Versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia · Source last updated 2023-11-18

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: 12 months
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
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 / 19	12 / 19	0 / 19
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 / 28	18 / 28	0 / 28

Group identifiers: EG000: Sonopet Ultrasonic Aspirator · EG001: CO2 Laser Ablation

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
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
2
num At Risk
28
num Events
2
term
discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
4
num At Risk
19
num Events
4
group Id
EG001
num Affected
4
num At Risk
28
num Events
4
term
pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
stats
group Id
EG000
num Affected
0
num At Risk
19
num Events
0
group Id
EG001
num Affected
3
num At Risk
28
num Events
3
term
vaginal bleeding
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
stats
group Id
EG000
num Affected
3
num At Risk
19
num Events
3
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
discharge
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
term
anal pruritus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
2
num At Risk
28
num Events
2
term
tenderness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
19
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
19
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
irritation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
19
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
yeast infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
itching
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Surgical and medical procedures
stats
group Id
EG000
num Affected
0
num At Risk
19
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
soreness at site

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
19
description
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
id
EG000
other Num Affected
12
other Num At Risk
19
serious Num Affected
0
serious Num At Risk
19
title
Sonopet Ultrasonic Aspirator
deaths Num Affected
0
deaths Num At Risk
28
description
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
id
EG001
other Num Affected
18
other Num At Risk
28
serious Num Affected
0
serious Num At Risk
28
title
CO2 Laser Ablation

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
2
num At Risk
28
num Events
2
term
discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
4
num At Risk
19
num Events
4
group Id
EG001
num Affected
4
num At Risk
28
num Events
4
term
pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
stats
group Id
EG000
num Affected
0
num At Risk
19
num Events
0
group Id
EG001
num Affected
3
num At Risk
28
num Events
3
term
vaginal bleeding
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
stats
group Id
EG000
num Affected
3
num At Risk
19
num Events
3
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
discharge
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
0
num At Risk
28
num Events
0
term
anal pruritus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
2
num At Risk
28
num Events
2
term
tenderness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
19
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
19
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
irritation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
0
num At Risk
19
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
yeast infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
19
num Events
1
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
itching
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Surgical and medical procedures
stats
group Id
EG000
num Affected
0
num At Risk
19
num Events
0
group Id
EG001
num Affected
1
num At Risk
28
num Events
1
term
soreness at site

time Frame

12 months

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Preserved source evidence · Not medical advice