NCT01422408 · ADVERSE EVENTS

Adverse events

Fluocinonide Cream in Treating Symptoms of Vaginal Dryness and Painful Sexual Intercourse In Patients With Breast Cancer Undergoing Hormone Therapy · Source last updated 2017-08-09

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: End of study week 1, 2, 3, 4
Other-event reporting threshold: 0%

Toxicities and adverse events will be assessed using the NCI Common Toxicity Criteria (CTC) Version 4.0. Since CTEP has standardized the CTC, the NCI does not require the inclusion of the CTC within the protocol document. A copy can be downloaded from the CTEP home page (http://ctep.info.nih.gov).

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Supportive Care (Fluocinonide Cream) This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.	0 / 34	24 / 34	0 / 34

Group identifiers: EG000: Supportive Care (Fluocinonide Cream)

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
Skin and subcutaneous tissue disorders
source Vocabulary
NCI CTCAE Version 4.
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Bullous dermatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
NCI CTCAE Version 4.
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Flushing
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
NCI CTCAE Version 4.
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
NCI CTCAE Version 4.
stats
group Id
EG000
num Affected
23
num At Risk
34
num Events
23
term
Pain of skin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
NCI CTCAE Version 4.
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Pruritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
NCI CTCAE Version 4.
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Rash acneiform
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
NCI CTCAE Version 4.
stats
group Id
EG000
num Affected
2
num At Risk
34
num Events
2
term
Vaginal discharge
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
NCI CTCAE Version 4.
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Vaginal inflammation

Complete source fields

description

event Groups

deaths Num Affected
0
deaths Num At Risk
34
description
This is a single-arm, single-stage, open-label phase II trial of topical fluocinonide 0.05% cream to improve vaginal symptoms. All subjects will receive topical fluocinonide 0.05% cream to apply twice daily for two weeks and then once daily for two weeks to the vagina. The duration of treatment will be 4 weeks.
id
EG000
other Num Affected
24
other Num At Risk
34
serious Num Affected
0
serious Num At Risk
34
title
Supportive Care (Fluocinonide Cream)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
NCI CTCAE Version 4.
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Bullous dermatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
NCI CTCAE Version 4.
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Flushing
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
NCI CTCAE Version 4.
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
NCI CTCAE Version 4.
stats
group Id
EG000
num Affected
23
num At Risk
34
num Events
23
term
Pain of skin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
NCI CTCAE Version 4.
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Pruritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
NCI CTCAE Version 4.
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Rash acneiform
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
NCI CTCAE Version 4.
stats
group Id
EG000
num Affected
2
num At Risk
34
num Events
2
term
Vaginal discharge
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
NCI CTCAE Version 4.
stats
group Id
EG000
num Affected
1
num At Risk
34
num Events
1
term
Vaginal inflammation

time Frame

End of study week 1, 2, 3, 4

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

Preserved source evidence · Not medical advice