NCT01367301 · ADVERSE EVENTS

Adverse events

Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With Uterine Cancer · Source last updated 2023-08-21

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: Every 3 months for the first 2 years and every 6 months for the next 3 years. Up to 5 years total as described in Section 7.4 of the Study Protocol.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Treatment (Paclitaxel, Carboplatin, Radiotherapy) CHEMOTHERAPY (weeks 1-9, 14-22): Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses during weeks 1-9 and 14-22. RADIATION THERAPY (weeks 8-16): Patients undergo external beam pelvic radiation therapy once a day, 5 days a week for 5 weeks during weeks 8-13. Patients then undergo HDR brachytherapy or IMRT once weekly during weeks 14-16. paclitaxel: Given IV carboplatin: Given IV external beam radiation therapy: Undergo external beam radiation therapy brachytherapy: Undergo HDR brachytherapy intensity-modulated radiation therapy: Undergo IMRT laboratory biomarker analysis: Correlative studies	0 / 11	2 / 11	0 / 11

Group identifiers: EG000: Treatment (Paclitaxel, Carboplatin, Radiotherapy)

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
NON_SYSTEMATIC_ASSESSMENT
notes
Both Grade 1 events
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
2
term
Hypokalemia
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
11
num Events
1
term
Hypomagnesemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 2
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Urinary Tract Infection
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
11
num Events
1
term
Acute Kidney Injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 1
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Verbatim term Neutropenia. Grade 1
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 2
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Alopecia
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
11
num Events
1
term
Peripheral Sensory Neuropathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 1
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Papulopustular Rash
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 1
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 2
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
2
term
Leukopenia

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
11
description
CHEMOTHERAPY (weeks 1-9, 14-22): Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses during weeks 1-9 and 14-22. RADIATION THERAPY (weeks 8-16): Patients undergo external beam pelvic radiation therapy once a day, 5 days a week for 5 weeks during weeks 8-13. Patients then undergo HDR brachytherapy or IMRT once weekly during weeks 14-16. paclitaxel: Given IV carboplatin: Given IV external beam radiation therapy: Undergo external beam radiation therapy brachytherapy: Undergo HDR brachytherapy intensity-modulated radiation therapy: Undergo IMRT laboratory biomarker analysis: Correlative studies
id
EG000
other Num Affected
2
other Num At Risk
11
serious Num Affected
0
serious Num At Risk
11
title
Treatment (Paclitaxel, Carboplatin, Radiotherapy)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Both Grade 1 events
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
2
term
Hypokalemia
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
11
num Events
1
term
Hypomagnesemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 2
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Urinary Tract Infection
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
11
num Events
1
term
Acute Kidney Injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 1
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Verbatim term Neutropenia. Grade 1
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Febrile Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 2
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Alopecia
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
11
num Events
1
term
Peripheral Sensory Neuropathy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 1
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Papulopustular Rash
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 1
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
notes
Grade 2
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
2
term
Leukopenia

time Frame

Every 3 months for the first 2 years and every 6 months for the next 3 years. Up to 5 years total as described in Section 7.4 of the Study Protocol.

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

Preserved source evidence · Not medical advice