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NCT00304031 · OUTCOME

Mean MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score Over Time

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

The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). The symptom severity score is the average of the symptom severity items, given a specified minimum numbers were completed.

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.

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 TMZ95
Dose-dense Adjuvant TMZ96

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Conventional Adjuvant TMZ88
Dose-dense Adjuvant TMZ86
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Conventional Adjuvant TMZ1.3Not reported1.01.5Not reported
Dose-dense Adjuvant TMZ1.1Not reported0.81.4Not reported
Week 10 (Cycle 1)

Analysis denominator · Participants

GroupSource count
Conventional Adjuvant TMZ73
Dose-dense Adjuvant TMZ74
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Conventional Adjuvant TMZ1.4Not reported1.11.7Not reported
Dose-dense Adjuvant TMZ1.4Not reported1.11.6Not reported
Week 12 (Cycle 1.5)

Analysis denominator · Participants

GroupSource count
Conventional Adjuvant TMZ41
Dose-dense Adjuvant TMZ37
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Conventional Adjuvant TMZ1.6Not reported1.22.1Not reported
Dose-dense Adjuvant TMZ1.5Not reported1.11.8Not reported
Week 22 (Cycle 4)

Analysis denominator · Participants

GroupSource count
Conventional Adjuvant TMZ51
Dose-dense Adjuvant TMZ40
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Conventional Adjuvant TMZ1.0Not reported0.71.3Not reported
Dose-dense Adjuvant TMZ1.2Not reported0.91.5Not reported
Week 24 (Cycle 4.5)

Analysis denominator · Participants

GroupSource count
Conventional Adjuvant TMZ32
Dose-dense Adjuvant TMZ24
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Conventional Adjuvant TMZ1.0Not reported0.71.3Not reported
Dose-dense Adjuvant TMZ1.1Not reported0.71.6Not reported
Week 46 (Cycle 10)

Analysis denominator · Participants

GroupSource count
Conventional Adjuvant TMZ24
Dose-dense Adjuvant TMZ22
Values in score on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Conventional Adjuvant TMZ1.2Not reported0.71.6Not reported
Dose-dense Adjuvant TMZ1.1Not reported0.71.6Not 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 MDASI Symptom Severity Score (baseline, 10, 12, 22, 24, 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 Comment
    Each explanatory variable is reported separately. (Time and intercept effects are not shown.)
    non Inferiority Type
    SUPERIORITY
    p Value
    0.1702
    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, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. RPA is reported here.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.8159
    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, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (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
    0.2174
    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 MDASI Symptom Severity Score (baseline, 10, 12, 22, 24, 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 Comment
    Each explanatory variable is reported separately. (Time and intercept effects are not shown.)
    non Inferiority Type
    SUPERIORITY
    p Value
    0.1702
    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, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (RPA) class, MGMT status, and time were included in the model. RPA is reported here.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.8159
    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, 46 weeks) as the outcome of interest. Treatment arm, recursive partitioning analysis (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
    0.2174
    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
        1.0
        upper Limit
        1.5
        value
        1.3
      2. group Id
        OG001
        lower Limit
        0.8
        upper Limit
        1.4
        value
        1.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        88
      2. group Id
        OG001
        value
        86
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.1
        upper Limit
        1.7
        value
        1.4
      2. group Id
        OG001
        lower Limit
        1.1
        upper Limit
        1.6
        value
        1.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        73
      2. group Id
        OG001
        value
        74
      units
      Participants
    title
    Week 10 (Cycle 1)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.2
        upper Limit
        2.1
        value
        1.6
      2. group Id
        OG001
        lower Limit
        1.1
        upper Limit
        1.8
        value
        1.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        41
      2. group Id
        OG001
        value
        37
      units
      Participants
    title
    Week 12 (Cycle 1.5)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.7
        upper Limit
        1.3
        value
        1.0
      2. group Id
        OG001
        lower Limit
        0.9
        upper Limit
        1.5
        value
        1.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        51
      2. group Id
        OG001
        value
        40
      units
      Participants
    title
    Week 22 (Cycle 4)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.7
        upper Limit
        1.3
        value
        1.0
      2. group Id
        OG001
        lower Limit
        0.7
        upper Limit
        1.6
        value
        1.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        24
      units
      Participants
    title
    Week 24 (Cycle 4.5)
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.7
        upper Limit
        1.6
        value
        1.2
      2. group Id
        OG001
        lower Limit
        0.7
        upper Limit
        1.6
        value
        1.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        24
      2. group Id
        OG001
        value
        22
      units
      Participants
    title
    Week 46 (Cycle 10)
denoms
  1. counts
    1. group Id
      OG000
      value
      95
    2. group Id
      OG001
      value
      96
    units
    Participants
description
The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). The symptom severity score is the average of the symptom severity items, given a specified minimum numbers were completed.
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.
    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
Mean MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score Over Time
type
SECONDARY
unit Of Measure
score on a scale

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice