NCT04493333 · ADVERSE EVENTS

Adverse events

Vaginal Dehydroepiandrosterone (DHEA) in Postmenopausal Breast Cancer Survivors on Aromatase Inhibitors · Source last updated 2024-11-27

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 weeks (+/- 1 week)
Other-event reporting threshold: 0%

AEs are to be reported in a routine fashion at scheduled times during the trial. Certain AEs must be reported in an expedited fashion to allow for timely monitoring of subject safety and care.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Intrarosa & Standard of Care Aromatase Inhibitor Subjects randomized to the Intrarosa® arm will use 6.5 mg daily for 12 weeks (±1 week).	0 / 5	4 / 5	0 / 5
Replens & Standard of Care Aromatase Inhibitor Subjects randomized to the Replens™ arm will use a vaginal applicator two times per week for 12 weeks (±1 week).	0 / 3	1 / 3	0 / 3

Group identifiers: EG000: Intrarosa & Standard of Care Aromatase Inhibitor · EG001: Replens & Standard of Care Aromatase Inhibitor

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
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Bloating
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Burning with vaginal Intrarosa application
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Dyspareunia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
3
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Herpes simplex reactivation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Hirsutism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
term
Hypokalemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Insomnia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Irritability
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Other, specify: Vaginal pulsing sensation

Complete source fields

description

AEs are to be reported in a routine fashion at scheduled times during the trial. Certain AEs must be reported in an expedited fashion to allow for timely monitoring of subject safety and care.

event Groups

deaths Num Affected
0
deaths Num At Risk
5
description
Subjects randomized to the Intrarosa® arm will use 6.5 mg daily for 12 weeks (±1 week).
id
EG000
other Num Affected
4
other Num At Risk
5
serious Num Affected
0
serious Num At Risk
5
title
Intrarosa & Standard of Care Aromatase Inhibitor
deaths Num Affected
0
deaths Num At Risk
3
description
Subjects randomized to the Replens™ arm will use a vaginal applicator two times per week for 12 weeks (±1 week).
id
EG001
other Num Affected
1
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Replens & Standard of Care Aromatase Inhibitor

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Bloating
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Burning with vaginal Intrarosa application
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Dyspareunia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
3
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Herpes simplex reactivation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Hirsutism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
0
num At Risk
5
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
term
Hypokalemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
2
num At Risk
5
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Insomnia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Irritability
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
source Vocabulary
CTCAE (5.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
term
Other, specify: Vaginal pulsing sensation

time Frame

12 weeks (+/- 1 week)

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

Preserved source evidence · Not medical advice