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NCT00248560 · OUTCOME

Toxicity as Measured by Number and Grade of Adverse Events

Gemcitabine and Docetaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer · Source last updated 2019-03-05

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Every 2 weeks

What was measured

Toxicity as the total number of participants with a given grade 3 and/or grade 4 adverse event

Groups in this outcome

Gemcitabine, Docetaxel

Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.

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

Analysis denominator · Participants

GroupSource count
Gemcitabine, Docetaxel36

Reported measurements

Anemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Docetaxel13Not reportedNot reportedNot reportedNot reported
Neutropenia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Docetaxel10Not reportedNot reportedNot reportedNot reported
Hyponatremia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Docetaxel10Not reportedNot reportedNot reportedNot reported
Dehydration
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Docetaxel3Not reportedNot reportedNot reportedNot reported
Fatigue
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Docetaxel3Not reportedNot reportedNot reportedNot reported
Dyspnea
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Docetaxel3Not reportedNot reportedNot reportedNot reported
Pneumonia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Docetaxel3Not reportedNot reportedNot reportedNot reported
Thrombocytopenia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Docetaxel2Not reportedNot reportedNot reportedNot reported
Febrile neutropenia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Docetaxel1Not reportedNot reportedNot reportedNot reported
Tachycardia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Docetaxel1Not reportedNot reportedNot reportedNot reported
Syncope
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Docetaxel1Not reportedNot reportedNot reportedNot reported
Fluid retention
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Docetaxel1Not reportedNot reportedNot reportedNot reported
Mucositis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Docetaxel1Not reportedNot reportedNot reportedNot reported
Hyperglycemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Docetaxel1Not reportedNot reportedNot reportedNot reported
Constipation
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Docetaxel1Not reportedNot reportedNot reportedNot reported
Anorexia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Docetaxel1Not reportedNot reportedNot reportedNot reported
Vomiting
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Docetaxel1Not reportedNot reportedNot reportedNot reported
Other non-hematologic toxicity
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine, Docetaxel1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        13
    title
    Anemia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        10
    title
    Neutropenia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        10
    title
    Hyponatremia
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Dehydration
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Fatigue
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Dyspnea
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Pneumonia
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Thrombocytopenia
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Febrile neutropenia
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Tachycardia
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Syncope
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Fluid retention
denoms
  1. counts
    1. group Id
      OG000
      value
      36
    units
    Participants
description
Toxicity as the total number of participants with a given grade 3 and/or grade 4 adverse event
groups
  1. description
    Gemcitabine given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine.
    id
    OG000
    title
    Gemcitabine, Docetaxel
param Type
NUMBER
reporting Status
POSTED
time Frame
Every 2 weeks
title
Toxicity as Measured by Number and Grade of Adverse Events
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice