NCT01958580 · ADVERSE EVENTS

Adverse events

Gemcitabine Hydrochloride, Docetaxel, and Radiation Therapy in Treating Patients With Uterine Sarcoma That Has Been Removed By Surgery · Source last updated 2023-08-16

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: Up to 1 year following completion of treatment (~69 weeks total)
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Treatment (Gemcitabine, Docetaxel, Brachytherapy/IMRT, EBRT) CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. RADIATION THERAPY: Beginning week 10, patients undergo 3 fractions of brachytherapy or IMRT over 3 weeks. Patients then undergo EBRT QD 5 days a week for 5 weeks. Gemcitabine Hydrochloride: Given IV Docetaxel: Given IV Internal Radiation Therapy: Undergo brachytherapy Intensity-Modulated Radiation Therapy: Undergo IMRT External Beam Radiation Therapy: Undergo EBRT Laboratory Biomarker Analysis: Correlative studies	1 / 3	1 / 3	0 / 3

Group identifiers: EG000: Treatment (Gemcitabine, Docetaxel, Brachytherapy/IMRT, EBRT)

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 3
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
term
Anemia

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
NON_SYSTEMATIC_ASSESSMENT
notes
Episodic. Grade 1-2
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
6
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 1
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Skin Hyperpigmentation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 1-2. Bilateral lower extremities
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
term
Edema Limbs
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 1
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
term
Hyperkalemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 1
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Nephrotoxicity
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 1
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 1
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Shoulder Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 1
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Cough
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 1
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Peripheral Neuropathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 1
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 1
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Alopecia

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
3
description
CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. RADIATION THERAPY: Beginning week 10, patients undergo 3 fractions of brachytherapy or IMRT over 3 weeks. Patients then undergo EBRT QD 5 days a week for 5 weeks. Gemcitabine Hydrochloride: Given IV Docetaxel: Given IV Internal Radiation Therapy: Undergo brachytherapy Intensity-Modulated Radiation Therapy: Undergo IMRT External Beam Radiation Therapy: Undergo EBRT Laboratory Biomarker Analysis: Correlative studies
id
EG000
other Num Affected
1
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Treatment (Gemcitabine, Docetaxel, Brachytherapy/IMRT, EBRT)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Episodic. Grade 1-2
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
6
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 1
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Skin Hyperpigmentation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 1-2. Bilateral lower extremities
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
term
Edema Limbs
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 1
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
term
Hyperkalemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 1
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Nephrotoxicity
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 1
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 1
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Shoulder Pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 1
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Cough
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 1
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Peripheral Neuropathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 1
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 1
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
term
Alopecia

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 3
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
term
Anemia

time Frame

Up to 1 year following completion of treatment (~69 weeks total)

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

Preserved source evidence · Not medical advice