NCT00068406 · ADVERSE EVENTS

Adverse events

Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Locally Advanced Cancer of the Vulva · Source last updated 2017-11-20

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: SAE (Serious Adverse Events): All adverse events occurring during study chemo radiation treatment period and up to 30 days after stopping the study treatment are reported without regard to attribution. Up to eleven weeks from the start of study treatment. OAE(Other Adverse Events): All treatment-related adverse events occurring during study chemo radiation treatment period and up to 30 days after stopping the study treatment are reported. Up to eleven weeks from the start of study treatment.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cisplatin + Radiation, Then Surgery Radiation therapy to the vulva, inguinal-femoral, and lower pelvic lymph nodes by AP-PA fields (180 cGy/daily fraction X 5 days, repeated weekly to a total of 32 fractions- total dose 5760 Gy). Concurrent cisplatin (40 mg/m2) chemotherapy administered weekly throughout radiation therapy. Six to eight weeks following the completion of chemoradiation - surgical excision of gross residual disease in the vulva and/or inguinal-femoral lymph nodes (if the inguinal-femoral nodes were considered unresectable prior to chemoradiation).	17 / 58	58 / 58	Not reported / Not reported

Group identifiers: EG000: Cisplatin + Radiation, Then Surgery

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
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
2
num At Risk
58
term
Thrombosis Embolism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
term
Ischemia/Cardiac Infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
term
Diarrhea Without Colostomy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
term
Dehydration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
term
Febrile With Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
term
Infection Without Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
term
Infection Other
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
term
Hypercalcemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
term
Hyperkalemia

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
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
42
num At Risk
58
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
51
num At Risk
58
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
30
num At Risk
58
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
28
num At Risk
58
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
13
num At Risk
58
term
Otherhematologic
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
2
num At Risk
58
term
Lymphatics
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
10
num At Risk
58
term
Cardiovascular
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
3
num At Risk
58
term
Hearing
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
8
num At Risk
58
term
Endocrine
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
term
Ocular
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
43
num At Risk
58
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
28
num At Risk
58
term
Vomiting

Complete source fields

event Groups

description
Radiation therapy to the vulva, inguinal-femoral, and lower pelvic lymph nodes by AP-PA fields (180 cGy/daily fraction X 5 days, repeated weekly to a total of 32 fractions- total dose 5760 Gy). Concurrent cisplatin (40 mg/m2) chemotherapy administered weekly throughout radiation therapy. Six to eight weeks following the completion of chemoradiation - surgical excision of gross residual disease in the vulva and/or inguinal-femoral lymph nodes (if the inguinal-femoral nodes were considered unresectable prior to chemoradiation).
id
EG000
other Num Affected
58
other Num At Risk
58
serious Num Affected
17
serious Num At Risk
58
title
Cisplatin + Radiation, Then Surgery

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
42
num At Risk
58
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
51
num At Risk
58
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
30
num At Risk
58
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
28
num At Risk
58
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
13
num At Risk
58
term
Otherhematologic
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
2
num At Risk
58
term
Lymphatics
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
10
num At Risk
58
term
Cardiovascular
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
3
num At Risk
58
term
Hearing
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
8
num At Risk
58
term
Endocrine
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
term
Ocular
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
43
num At Risk
58
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
28
num At Risk
58
term
Vomiting

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
term
Anemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
2
num At Risk
58
term
Thrombosis Embolism
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
term
Ischemia/Cardiac Infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
term
Vomiting
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
term
Diarrhea Without Colostomy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
term
Dehydration
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
term
Febrile With Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
term
Infection Without Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
term
Infection Other
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
term
Hypercalcemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (2.0)
stats
group Id
EG000
num Affected
1
num At Risk
58
term
Hyperkalemia

time Frame

SAE (Serious Adverse Events): All adverse events occurring during study chemo radiation treatment period and up to 30 days after stopping the study treatment are reported without regard to attribution. Up to eleven weeks from the start of study treatment. OAE(Other Adverse Events): All treatment-related adverse events occurring during study chemo radiation treatment period and up to 30 days after stopping the study treatment are reported. Up to eleven weeks from the start of study treatment.

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Preserved source evidence · Not medical advice