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NCT00304031 · OUTCOME

Change From Baseline in Mean EORTC QLQ-C30 Global Health Status

Radiation Therapy (RT) and Temozolomide (TMZ) in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma · Source last updated 2020-06-09

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

Measure
MEAN
Unit
score on a scale
Interval / dispersion
95% Confidence Interval
Time frame
Baseline, 10,12, 22, 24, and 46 weeks

What was measured

Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-C30. The question responses range from 1 "very poor" to 7 "excellent" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Change from baseline was calculated as time point value - baseline value with a positive change value indicating improved QOL from baseline.

Analysis population: Questionnaires were not completed by all QOL population participants. Therefore, the number of participants reported below are the number with the relevant questions answered at baseline and the given time point on each arm.

Groups in this outcome

Conventional Adjuvant TMZ

Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle for 6 cycles, up to 12 cycles.

Dose-dense Adjuvant TMZ

Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle for 6 cycles, up to 12 cycles.

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

Analysis denominator · Participants

GroupSource count
Conventional Adjuvant TMZ96
Dose-dense Adjuvant TMZ95

Reported measurements

Week 10 (Cycle 1)

Analysis denominator · Participants

GroupSource count
Conventional Adjuvant TMZ70
Dose-dense Adjuvant TMZ72
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Conventional Adjuvant TMZ0.0Not reported-6.16.1Not reported
Dose-dense Adjuvant TMZ-2.9Not reported-8.72.9Not reported
Week 12 (Cycle 1.5)

Analysis denominator · Participants

GroupSource count
Conventional Adjuvant TMZ40
Dose-dense Adjuvant TMZ38
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Conventional Adjuvant TMZ-4.6Not reported-12.63.5Not reported
Dose-dense Adjuvant TMZ-2.7Not reported-11.36.1Not reported
Week 22 (Cycle 4)

Analysis denominator · Participants

GroupSource count
Conventional Adjuvant TMZ48
Dose-dense Adjuvant TMZ38
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Conventional Adjuvant TMZ3.9Not reported-2.510.4Not reported
Dose-dense Adjuvant TMZ-4.4Not reported-12.13.3Not reported
Week 24 (Cycle 4.5)

Analysis denominator · Participants

GroupSource count
Conventional Adjuvant TMZ30
Dose-dense Adjuvant TMZ23
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Conventional Adjuvant TMZ-2.8Not reported-13.98.3Not reported
Dose-dense Adjuvant TMZ-0.7Not reported-11.910.5Not reported
Week 46 (Cycle 10)

Analysis denominator · Participants

GroupSource count
Conventional Adjuvant TMZ23
Dose-dense Adjuvant TMZ22
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Conventional Adjuvant TMZ5.4Not reported-7.518.3Not reported
Dose-dense Adjuvant TMZ-1.9Not reported-9.86.0Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Description
    A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10,12, 22, 24, and 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. Treatment arm is reported here.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2184
    statistical Comment
    Each explanatory variable is reported separately. (Time and intercept effects are not shown.)
    statistical Method
    Mixed Models Analysis
  2. group Description
    A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10,12, 22, 24, and 46 weeks) as the outcome of interest. Treatment arm, RPA class, MGMT status, and time were included in the model. RPA class is reported here.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0763
    statistical Comment
    Each explanatory variable is reported separately. (Time and intercept effects are not shown.)
    statistical Method
    Mixed Models Analysis
  3. group Description
    A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10,12, 22, 24, and 46 weeks) as the outcome of interest. Treatment arm, RPA class, MGMT status, and time were included in the model. MGMT status is reported here.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.5235
    statistical Comment
    Each explanatory variable is reported separately. (Time and intercept effects are not shown.)
    statistical Method
    Mixed Models Analysis
Complete source fields
analyses
  1. group Description
    A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10,12, 22, 24, and 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. Treatment arm is reported here.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2184
    statistical Comment
    Each explanatory variable is reported separately. (Time and intercept effects are not shown.)
    statistical Method
    Mixed Models Analysis
  2. group Description
    A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10,12, 22, 24, and 46 weeks) as the outcome of interest. Treatment arm, RPA class, MGMT status, and time were included in the model. RPA class is reported here.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0763
    statistical Comment
    Each explanatory variable is reported separately. (Time and intercept effects are not shown.)
    statistical Method
    Mixed Models Analysis
  3. group Description
    A mixed effects model was run with EORTC QLQ-C30 Global Health Status Score (baseline, 10,12, 22, 24, and 46 weeks) as the outcome of interest. Treatment arm, RPA class, MGMT status, and time were included in the model. MGMT status is reported here.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.5235
    statistical Comment
    Each explanatory variable is reported separately. (Time and intercept effects are not shown.)
    statistical Method
    Mixed Models Analysis
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -6.1
        upper Limit
        6.1
        value
        0.0
      2. group Id
        OG001
        lower Limit
        -8.7
        upper Limit
        2.9
        value
        -2.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        70
      2. group Id
        OG001
        value
        72
      units
      Participants
    title
    Week 10 (Cycle 1)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -12.6
        upper Limit
        3.5
        value
        -4.6
      2. group Id
        OG001
        lower Limit
        -11.3
        upper Limit
        6.1
        value
        -2.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        40
      2. group Id
        OG001
        value
        38
      units
      Participants
    title
    Week 12 (Cycle 1.5)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -2.5
        upper Limit
        10.4
        value
        3.9
      2. group Id
        OG001
        lower Limit
        -12.1
        upper Limit
        3.3
        value
        -4.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        48
      2. group Id
        OG001
        value
        38
      units
      Participants
    title
    Week 22 (Cycle 4)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -13.9
        upper Limit
        8.3
        value
        -2.8
      2. group Id
        OG001
        lower Limit
        -11.9
        upper Limit
        10.5
        value
        -0.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        30
      2. group Id
        OG001
        value
        23
      units
      Participants
    title
    Week 24 (Cycle 4.5)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -7.5
        upper Limit
        18.3
        value
        5.4
      2. group Id
        OG001
        lower Limit
        -9.8
        upper Limit
        6.0
        value
        -1.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        22
      units
      Participants
    title
    Week 46 (Cycle 10)
denoms
  1. counts
    1. group Id
      OG000
      value
      96
    2. group Id
      OG001
      value
      95
    units
    Participants
description
Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-C30. The question responses range from 1 "very poor" to 7 "excellent" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Change from baseline was calculated as time point value - baseline value with a positive change value indicating improved QOL from baseline.
dispersion Type
95% Confidence Interval
groups
  1. description
    Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle for 6 cycles, up to 12 cycles.
    id
    OG000
    title
    Conventional Adjuvant TMZ
  2. description
    Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle for 6 cycles, up to 12 cycles.
    id
    OG001
    title
    Dose-dense Adjuvant TMZ
param Type
MEAN
population Description
Questionnaires were not completed by all QOL population participants. Therefore, the number of participants reported below are the number with the relevant questions answered at baseline and the given time point on each arm.
reporting Status
POSTED
time Frame
Baseline, 10,12, 22, 24, and 46 weeks
title
Change From Baseline in Mean EORTC QLQ-C30 Global Health Status
type
SECONDARY
unit Of Measure
score on a scale

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Preserved source evidence · Not medical advice