NCT03509207 · ADVERSE EVENTS

Adverse events

Vorinostat (SAHA) in Uterine Sarcoma · Source last updated 2020-08-04

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: From enrolment to study completion per Patient, up to 41 weeks.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Vorinostat, Zolinza Oral Capsules Vorinostat Oral Capsules 400mg daily Vorinostat Oral Capsule: Vorinostat, 400 mg orally once daily for the first 14 days of a 21 day cycle Treatment will be continued for 4 cycles. Patients with a response or stable disease after 4 cycles will be continued on vorinostat therapy at the tolerated schedule and dosage until disease progression, unacceptable toxicity or patients' withdrawal of the consent. At the maximum, a total of 12 cycles will be administered over a period of 9 months.	2 / 3	0 / 3	2 / 3

Group identifiers: EG000: Vorinostat, Zolinza Oral Capsules

Serious 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
Reproductive system and breast disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
term
Death of uterine carcinoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
term
pleural effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
abscess of the vaginal vault

Other reported adverse events

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

Complete source fields

event Groups

deaths Num Affected
2
deaths Num At Risk
3
description
Vorinostat Oral Capsules 400mg daily Vorinostat Oral Capsule: Vorinostat, 400 mg orally once daily for the first 14 days of a 21 day cycle Treatment will be continued for 4 cycles. Patients with a response or stable disease after 4 cycles will be continued on vorinostat therapy at the tolerated schedule and dosage until disease progression, unacceptable toxicity or patients' withdrawal of the consent. At the maximum, a total of 12 cycles will be administered over a period of 9 months.
id
EG000
other Num Affected
0
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Vorinostat, Zolinza Oral Capsules

frequency Threshold

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
term
Death of uterine carcinoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
term
pleural effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Reproductive system and breast disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
abscess of the vaginal vault

time Frame

From enrolment to study completion per Patient, up to 41 weeks.

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

Preserved source evidence · Not medical advice