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NCT01207388 · OUTCOME

Change From Baseline in EORTC-QLQ-C30 Scales

Confirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL) · Source last updated 2020-02-10

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

Measure
MEAN
Unit
units on a scale
Interval / dispersion
Standard Error
Time frame
Baseline and the end of each treatment cycle (day 29 of each cycle) and 30 days after end of the last infusion (end of the core study, a maximum of 26 weeks).

What was measured

The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Insomnia, Appetite Loss, Constipation, Diarrhea, Financial Impact). For each of these scales, scores range from 0 to 100. For the GHS and 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement. For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms. The maximum changes from baseline to cycles 1 through 4 and the change from baseline to the end of the core study are reported.

Analysis population: FAS with available data at relevant time points. For maximum change, the change from baseline was calculated using subset of FAS with available data (baseline and post-baseline) at the end of each cycle. The number analyzed are the number of subjects with available data at the time point at which maximum change from baseline was observed.

Groups in this outcome

Maximum Change From Baseline in Cycles 1 - 4

Not reported

Change From Baseline at End of Core Study

Not reported

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

Analysis denominator · Participants

GroupSource count
Maximum Change From Baseline in Cycles 1 - 4111
Change From Baseline at End of Core Study74

Reported measurements

Global Health Status

Analysis denominator · Participants

GroupSource count
Maximum Change From Baseline in Cycles 1 - 426
Change From Baseline at End of Core Study74
Values in units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Maximum Change From Baseline in Cycles 1 - 49.04.2Not reportedNot reportedNot reported
Change From Baseline at End of Core Study3.92.4Not reportedNot reportedNot reported
Physical Functioning

Analysis denominator · Participants

GroupSource count
Maximum Change From Baseline in Cycles 1 - 426
Change From Baseline at End of Core Study74
Values in units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Maximum Change From Baseline in Cycles 1 - 42.62.3Not reportedNot reportedNot reported
Change From Baseline at End of Core Study2.21.9Not reportedNot reportedNot reported
Role Functioning

Analysis denominator · Participants

GroupSource count
Maximum Change From Baseline in Cycles 1 - 415
Change From Baseline at End of Core Study72
Values in units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Maximum Change From Baseline in Cycles 1 - 412.28.5Not reportedNot reportedNot reported
Change From Baseline at End of Core Study1.43.5Not reportedNot reportedNot reported
Emotional Functioning

Analysis denominator · Participants

GroupSource count
Maximum Change From Baseline in Cycles 1 - 426
Change From Baseline at End of Core Study74
Values in units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Maximum Change From Baseline in Cycles 1 - 46.54.9Not reportedNot reportedNot reported
Change From Baseline at End of Core Study5.32.7Not reportedNot reportedNot reported
Cognitive Functioning

Analysis denominator · Participants

GroupSource count
Maximum Change From Baseline in Cycles 1 - 415
Change From Baseline at End of Core Study74
Values in units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Maximum Change From Baseline in Cycles 1 - 4-3.35.2Not reportedNot reportedNot reported
Change From Baseline at End of Core Study-2.32.5Not reportedNot reportedNot reported
Social Functioning

Analysis denominator · Participants

GroupSource count
Maximum Change From Baseline in Cycles 1 - 415
Change From Baseline at End of Core Study74
Values in units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Maximum Change From Baseline in Cycles 1 - 412.28.5Not reportedNot reportedNot reported
Change From Baseline at End of Core Study14.93.8Not reportedNot reportedNot reported
Fatigue Symptom

Analysis denominator · Participants

GroupSource count
Maximum Change From Baseline in Cycles 1 - 415
Change From Baseline at End of Core Study74
Values in units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Maximum Change From Baseline in Cycles 1 - 4-5.95.5Not reportedNot reportedNot reported
Change From Baseline at End of Core Study-5.42.4Not reportedNot reportedNot reported
Nausea and Vomiting Symptom

Analysis denominator · Participants

GroupSource count
Maximum Change From Baseline in Cycles 1 - 426
Change From Baseline at End of Core Study73
Values in units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Maximum Change From Baseline in Cycles 1 - 4-4.54.7Not reportedNot reportedNot reported
Change From Baseline at End of Core Study-2.32.0Not reportedNot reportedNot reported
Pain Symptom

Analysis denominator · Participants

GroupSource count
Maximum Change From Baseline in Cycles 1 - 426
Change From Baseline at End of Core Study74
Values in units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Maximum Change From Baseline in Cycles 1 - 43.83.6Not reportedNot reportedNot reported
Change From Baseline at End of Core Study-1.42.7Not reportedNot reportedNot reported
Dyspnea Symptom

Analysis denominator · Participants

GroupSource count
Maximum Change From Baseline in Cycles 1 - 426
Change From Baseline at End of Core Study74
Values in units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Maximum Change From Baseline in Cycles 1 - 4-9.04.7Not reportedNot reportedNot reported
Change From Baseline at End of Core Study-0.92.9Not reportedNot reportedNot reported
Insomnia Symptom

Analysis denominator · Participants

GroupSource count
Maximum Change From Baseline in Cycles 1 - 426
Change From Baseline at End of Core Study73
Values in units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Maximum Change From Baseline in Cycles 1 - 4-2.63.2Not reportedNot reportedNot reported
Change From Baseline at End of Core Study3.73.5Not reportedNot reportedNot reported
Appetite Loss Symptom

Analysis denominator · Participants

GroupSource count
Maximum Change From Baseline in Cycles 1 - 415
Change From Baseline at End of Core Study73
Values in units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Maximum Change From Baseline in Cycles 1 - 4-17.86.4Not reportedNot reportedNot reported
Change From Baseline at End of Core Study-9.13.4Not reportedNot reportedNot reported
Constipation Symptom

Analysis denominator · Participants

GroupSource count
Maximum Change From Baseline in Cycles 1 - 426
Change From Baseline at End of Core Study74
Values in units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Maximum Change From Baseline in Cycles 1 - 4-5.13.6Not reportedNot reportedNot reported
Change From Baseline at End of Core Study0.02.2Not reportedNot reportedNot reported
Diarrhea Symptom

Analysis denominator · Participants

GroupSource count
Maximum Change From Baseline in Cycles 1 - 426
Change From Baseline at End of Core Study74
Values in units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Maximum Change From Baseline in Cycles 1 - 45.15.5Not reportedNot reportedNot reported
Change From Baseline at End of Core Study0.02.3Not reportedNot reportedNot reported
Financial Difficulties Symptom

Analysis denominator · Participants

GroupSource count
Maximum Change From Baseline in Cycles 1 - 426
Change From Baseline at End of Core Study72
Values in units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Maximum Change From Baseline in Cycles 1 - 4-5.14.8Not reportedNot reportedNot reported
Change From Baseline at End of Core Study-0.92.9Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.2
        value
        9.0
      2. group Id
        OG001
        spread
        2.4
        value
        3.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        74
      units
      Participants
    title
    Global Health Status
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.3
        value
        2.6
      2. group Id
        OG001
        spread
        1.9
        value
        2.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        74
      units
      Participants
    title
    Physical Functioning
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.5
        value
        12.2
      2. group Id
        OG001
        spread
        3.5
        value
        1.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        72
      units
      Participants
    title
    Role Functioning
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.9
        value
        6.5
      2. group Id
        OG001
        spread
        2.7
        value
        5.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        74
      units
      Participants
    title
    Emotional Functioning
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.2
        value
        -3.3
      2. group Id
        OG001
        spread
        2.5
        value
        -2.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        74
      units
      Participants
    title
    Cognitive Functioning
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.5
        value
        12.2
      2. group Id
        OG001
        spread
        3.8
        value
        14.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        74
      units
      Participants
    title
    Social Functioning
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.5
        value
        -5.9
      2. group Id
        OG001
        spread
        2.4
        value
        -5.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        74
      units
      Participants
    title
    Fatigue Symptom
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.7
        value
        -4.5
      2. group Id
        OG001
        spread
        2.0
        value
        -2.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        73
      units
      Participants
    title
    Nausea and Vomiting Symptom
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.6
        value
        3.8
      2. group Id
        OG001
        spread
        2.7
        value
        -1.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        74
      units
      Participants
    title
    Pain Symptom
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.7
        value
        -9.0
      2. group Id
        OG001
        spread
        2.9
        value
        -0.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        74
      units
      Participants
    title
    Dyspnea Symptom
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.2
        value
        -2.6
      2. group Id
        OG001
        spread
        3.5
        value
        3.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        73
      units
      Participants
    title
    Insomnia Symptom
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.4
        value
        -17.8
      2. group Id
        OG001
        spread
        3.4
        value
        -9.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        73
      units
      Participants
    title
    Appetite Loss Symptom
denoms
  1. counts
    1. group Id
      OG000
      value
      111
    2. group Id
      OG001
      value
      74
    units
    Participants
description
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Insomnia, Appetite Loss, Constipation, Diarrhea, Financial Impact). For each of these scales, scores range from 0 to 100. For the GHS and 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement. For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms. The maximum changes from baseline to cycles 1 through 4 and the change from baseline to the end of the core study are reported.
dispersion Type
Standard Error
groups
  1. id
    OG000
    title
    Maximum Change From Baseline in Cycles 1 - 4
  2. id
    OG001
    title
    Change From Baseline at End of Core Study
param Type
MEAN
population Description
FAS with available data at relevant time points. For maximum change, the change from baseline was calculated using subset of FAS with available data (baseline and post-baseline) at the end of each cycle. The number analyzed are the number of subjects with available data at the time point at which maximum change from baseline was observed.
reporting Status
POSTED
time Frame
Baseline and the end of each treatment cycle (day 29 of each cycle) and 30 days after end of the last infusion (end of the core study, a maximum of 26 weeks).
title
Change From Baseline in EORTC-QLQ-C30 Scales
type
SECONDARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice