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NCT00068406 · OUTCOME

Treatment-Related Adverse Effects (Grade 3 or Higher) During Study Treatment Period

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Assessed every cycle while on treatment, 30 days after the last cycle of treatment. Up to eleven weeks from the start of study treatment

What was measured

Number of participants with a maximum grade of 3 or higher during the treatment period. Adverse events are graded and categorized using Common Terminology Criteria for Adverse Events Version 2.0

Analysis population: Eligible and treated patients

Groups in this outcome

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).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Cisplatin + Radiation, Then Surgery58

Reported measurements

Leukopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cisplatin + Radiation, Then Surgery18Not reportedNot reportedNot reportedNot reported
Anemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cisplatin + Radiation, Then Surgery4Not reportedNot reportedNot reportedNot reported
Thrombocytopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cisplatin + Radiation, Then Surgery3Not reportedNot reportedNot reportedNot reported
Neutropenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cisplatin + Radiation, Then Surgery11Not reportedNot reportedNot reportedNot reported
Other Hematologic
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cisplatin + Radiation, Then Surgery13Not reportedNot reportedNot reportedNot reported
Constitutional
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cisplatin + Radiation, Then Surgery5Not reportedNot reportedNot reportedNot reported
Cardiovascular
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cisplatin + Radiation, Then Surgery4Not reportedNot reportedNot reportedNot reported
Dermatologic
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cisplatin + Radiation, Then Surgery17Not reportedNot reportedNot reportedNot reported
Gastrointestinal
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cisplatin + Radiation, Then Surgery13Not reportedNot reportedNot reportedNot reported
Genitourinary/Renal
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cisplatin + Radiation, Then Surgery3Not reportedNot reportedNot reportedNot reported
hemorrhage
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cisplatin + Radiation, Then Surgery1Not reportedNot reportedNot reportedNot reported
Infection
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cisplatin + Radiation, Then Surgery8Not reportedNot reportedNot reportedNot reported
Metabolic
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cisplatin + Radiation, Then Surgery10Not reportedNot reportedNot reportedNot reported
Other Neurologic
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cisplatin + Radiation, Then Surgery2Not reportedNot reportedNot reportedNot reported
Pulmonary
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cisplatin + Radiation, Then Surgery1Not reportedNot reportedNot reportedNot reported
Pain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cisplatin + Radiation, Then Surgery10Not reportedNot reportedNot reportedNot reported
Sexual/reproductive
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cisplatin + Radiation, Then Surgery1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        18
    title
    Leukopenia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Anemia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Thrombocytopenia
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        11
    title
    Neutropenia
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        13
    title
    Other Hematologic
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Constitutional
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Cardiovascular
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        17
    title
    Dermatologic
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        13
    title
    Gastrointestinal
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Genitourinary/Renal
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    hemorrhage
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Infection
denoms
  1. counts
    1. group Id
      OG000
      value
      58
    units
    Participants
description
Number of participants with a maximum grade of 3 or higher during the treatment period. Adverse events are graded and categorized using Common Terminology Criteria for Adverse Events Version 2.0
groups
  1. 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
    OG000
    title
    Cisplatin + Radiation, Then Surgery
param Type
COUNT_OF_PARTICIPANTS
population Description
Eligible and treated patients
reporting Status
POSTED
time Frame
Assessed every cycle while on treatment, 30 days after the last cycle of treatment. Up to eleven weeks from the start of study treatment
title
Treatment-Related Adverse Effects (Grade 3 or Higher) During Study Treatment Period
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice