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NCT02302807 · OUTCOME

Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score: Global Health Status Scale

A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211] · Source last updated 2019-08-01

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

Measure
MEAN
Unit
units of a scale
Interval / dispersion
Standard Deviation
Time frame
Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days)

What was measured

The EORTC QLQ-C30 includes five functional scales (physical, role, cognitive, emotional, social); a global health status (GHS)/quality of life (QoL) scale; and items measuring fatigue, pain, nausea and vomiting, dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, and financial difficulties. The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms). Key scales included physical functioning, and fatigue, and GHS.

Analysis population: All randomized patients with non-missing baseline assessment and at least one non-missing post-baseline assessment.

Groups in this outcome

Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)

Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m\^2), paclitaxel 175 mg/m\^2, or docetaxel 75 mg/m\^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.

Atezolizumab

Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.

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

Analysis denominator · Participants

GroupSource count
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)381
Atezolizumab408

Reported measurements

Baseline (Cycle 1, Day 1)

Analysis denominator · Participants

GroupSource count
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)380
Atezolizumab407
Values in units of a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)61.4922.30Not reportedNot reportedNot reported
Atezolizumab64.1921.72Not reportedNot reportedNot reported
Change from baseline: Cycle 2, Day 1

Analysis denominator · Participants

GroupSource count
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)349
Atezolizumab379
Values in units of a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)-5.4720.02Not reportedNot reportedNot reported
Atezolizumab-6.1820.07Not reportedNot reportedNot reported
Change from baseline: Cycle 3, Day 1

Analysis denominator · Participants

GroupSource count
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)299
Atezolizumab328
Values in units of a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)-3.7622.34Not reportedNot reportedNot reported
Atezolizumab-4.6720.89Not reportedNot reportedNot reported
Change from baseline: Cycle 4, Day 1

Analysis denominator · Participants

GroupSource count
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)203
Atezolizumab250
Values in units of a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)-1.4819.71Not reportedNot reportedNot reported
Atezolizumab-0.5320.23Not reportedNot reportedNot reported
Change from baseline: Cycle 12, Day 1

Analysis denominator · Participants

GroupSource count
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)38
Atezolizumab104
Values in units of a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)-3.9524.33Not reportedNot reportedNot reported
Atezolizumab-0.5622.31Not reportedNot reportedNot reported
Change from baseline: Cycle 20, Day 1

Analysis denominator · Participants

GroupSource count
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)11
Atezolizumab68
Values in units of a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)-2.2716.28Not reportedNot reportedNot reported
Atezolizumab1.1021.88Not reportedNot reportedNot reported
Change from baseline: Cycle 28, Day 1

Analysis denominator · Participants

GroupSource count
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)5
Atezolizumab19
Values in units of a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)-11.677.45Not reportedNot reportedNot reported
Atezolizumab-5.2633.82Not reportedNot reportedNot reported
Change from baseline:Treatment Discont. Visit

Analysis denominator · Participants

GroupSource count
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)267
Atezolizumab200
Values in units of a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)-10.7724.15Not reportedNot reportedNot reported
Atezolizumab-16.7124.39Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.30
        value
        61.49
      2. group Id
        OG001
        spread
        21.72
        value
        64.19
    denoms
    1. counts
      1. group Id
        OG000
        value
        380
      2. group Id
        OG001
        value
        407
      units
      Participants
    title
    Baseline (Cycle 1, Day 1)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.02
        value
        -5.47
      2. group Id
        OG001
        spread
        20.07
        value
        -6.18
    denoms
    1. counts
      1. group Id
        OG000
        value
        349
      2. group Id
        OG001
        value
        379
      units
      Participants
    title
    Change from baseline: Cycle 2, Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.34
        value
        -3.76
      2. group Id
        OG001
        spread
        20.89
        value
        -4.67
    denoms
    1. counts
      1. group Id
        OG000
        value
        299
      2. group Id
        OG001
        value
        328
      units
      Participants
    title
    Change from baseline: Cycle 3, Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.71
        value
        -1.48
      2. group Id
        OG001
        spread
        20.23
        value
        -0.53
    denoms
    1. counts
      1. group Id
        OG000
        value
        203
      2. group Id
        OG001
        value
        250
      units
      Participants
    title
    Change from baseline: Cycle 4, Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.33
        value
        -3.95
      2. group Id
        OG001
        spread
        22.31
        value
        -0.56
    denoms
    1. counts
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        104
      units
      Participants
    title
    Change from baseline: Cycle 12, Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.28
        value
        -2.27
      2. group Id
        OG001
        spread
        21.88
        value
        1.10
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        68
      units
      Participants
    title
    Change from baseline: Cycle 20, Day 1
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.45
        value
        -11.67
      2. group Id
        OG001
        spread
        33.82
        value
        -5.26
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        19
      units
      Participants
    title
    Change from baseline: Cycle 28, Day 1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.15
        value
        -10.77
      2. group Id
        OG001
        spread
        24.39
        value
        -16.71
    denoms
    1. counts
      1. group Id
        OG000
        value
        267
      2. group Id
        OG001
        value
        200
      units
      Participants
    title
    Change from baseline:Treatment Discont. Visit
denoms
  1. counts
    1. group Id
      OG000
      value
      381
    2. group Id
      OG001
      value
      408
    units
    Participants
description
The EORTC QLQ-C30 includes five functional scales (physical, role, cognitive, emotional, social); a global health status (GHS)/quality of life (QoL) scale; and items measuring fatigue, pain, nausea and vomiting, dyspnea, appetite loss, sleep disturbance, constipation, diarrhea, and financial difficulties. The score range for each scale and single-item measure is 0 to 100, where higher scores indicate a higher response level (i.e., better functioning, better QoL, worse symptoms). Key scales included physical functioning, and fatigue, and GHS.
dispersion Type
Standard Deviation
groups
  1. description
    Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m\^2), paclitaxel 175 mg/m\^2, or docetaxel 75 mg/m\^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
    id
    OG000
    title
    Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)
  2. description
    Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
    id
    OG001
    title
    Atezolizumab
param Type
MEAN
population Description
All randomized patients with non-missing baseline assessment and at least one non-missing post-baseline assessment.
reporting Status
POSTED
time Frame
Cycle 1 Day 1 (prior to any health care interaction), on Day 1 of each subsequent cycle, and at 30 days after the last treatment dose (Up to approximately 25 months; each cycle is 21 days)
title
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) Score: Global Health Status Scale
type
SECONDARY
unit Of Measure
units of a scale

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Preserved source evidence · Not medical advice