NCT00542490 · ADVERSE EVENTS

Adverse events

Vaginal Cuff Brachytherapy Followed by Chemotherapy in Patients With Endometrioid Cancer · Source last updated 2020-08-21

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: 2 years
Other-event reporting threshold: 1%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Vaginal Cuff Brachytherapy Vaginal Cuff Brachytherapy: Clinical stage I-II endometrial cancer surgically staged. Stage I-II with any high-intermediate risk (H-IR) features OR Stage IIb any histology OR Stage I-II Papillary Serous or Clear Cell Histology Vaginal cuff brachytherapy Followed by Paclitaxel (175 mg/m2 over 3 hours) and carboplatin (AUC 6) Chemotherapy X 3 (high risk)	1 / 23	1 / 23	0 / 23

Group identifiers: EG000: Vaginal Cuff Brachytherapy

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
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
term
Pulmonary Embolism
assessment Type
SYSTEMATIC_ASSESSMENT
notes
gastrointestinal bleed following radiation therapy
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
term
Gastrointestinal bleed
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
term
neutropenic fever

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
23
num Events
1
term
Grade 4 Fatigue

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
23
description
Vaginal Cuff Brachytherapy: Clinical stage I-II endometrial cancer surgically staged. Stage I-II with any high-intermediate risk (H-IR) features OR Stage IIb any histology OR Stage I-II Papillary Serous or Clear Cell Histology Vaginal cuff brachytherapy Followed by Paclitaxel (175 mg/m2 over 3 hours) and carboplatin (AUC 6) Chemotherapy X 3 (high risk)
id
EG000
other Num Affected
1
other Num At Risk
23
serious Num Affected
1
serious Num At Risk
23
title
Vaginal Cuff Brachytherapy

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
term
Grade 4 Fatigue

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
term
Pulmonary Embolism
assessment Type
SYSTEMATIC_ASSESSMENT
notes
gastrointestinal bleed following radiation therapy
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
term
Gastrointestinal bleed
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
23
num Events
1
term
neutropenic fever

time Frame

2 years

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

Preserved source evidence · Not medical advice