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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: Fatigue Symptom 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

Fatigue Symptom: Baseline (Cycle 1, Day 1)

Analysis denominator · Participants

GroupSource count
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)381
Atezolizumab408
Values in units of a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)34.6726.66Not reportedNot reportedNot reported
Atezolizumab32.8723.88Not reportedNot reportedNot reported
Fatigue Symptom: Cycle 2, Day 1

Analysis denominator · Participants

GroupSource count
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)350
Atezolizumab385
Values in units of a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)10.7123.13Not reportedNot reportedNot reported
Atezolizumab10.5621.82Not reportedNot reportedNot reported
Change from baseline: Cycle 3, Day 1

Analysis denominator · Participants

GroupSource count
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)302
Atezolizumab329
Values in units of a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)11.0425.48Not reportedNot reportedNot reported
Atezolizumab9.4124.80Not reportedNot reportedNot reported
Change from baseline: Cycle 4, Day 1

Analysis denominator · Participants

GroupSource count
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)202
Atezolizumab254
Values in units of a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)7.4822.63Not reportedNot reportedNot reported
Atezolizumab3.6723.57Not reportedNot reportedNot reported
Change from baseline: Cycle 12, Day 1

Analysis denominator · Participants

GroupSource count
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)39
Atezolizumab105
Values in units of a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)5.7027.44Not reportedNot reportedNot reported
Atezolizumab-0.9523.27Not reportedNot reportedNot reported
Change from baseline: Cycle 20, Day 1

Analysis denominator · Participants

GroupSource count
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)11
Atezolizumab69
Values in units of a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)11.1128.97Not reportedNot reportedNot reported
Atezolizumab-8.0521.97Not 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)15.5616.85Not reportedNot reportedNot reported
Atezolizumab-12.2828.42Not reportedNot reportedNot reported
Change from baseline: Treatment Discont. Visit

Analysis denominator · Participants

GroupSource count
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)267
Atezolizumab201
Values in units of a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)17.2728.15Not reportedNot reportedNot reported
Atezolizumab19.6025.95Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        26.66
        value
        34.67
      2. group Id
        OG001
        spread
        23.88
        value
        32.87
    denoms
    1. counts
      1. group Id
        OG000
        value
        381
      2. group Id
        OG001
        value
        408
      units
      Participants
    title
    Fatigue Symptom: Baseline (Cycle 1, Day 1)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.13
        value
        10.71
      2. group Id
        OG001
        spread
        21.82
        value
        10.56
    denoms
    1. counts
      1. group Id
        OG000
        value
        350
      2. group Id
        OG001
        value
        385
      units
      Participants
    title
    Fatigue Symptom: Cycle 2, Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.48
        value
        11.04
      2. group Id
        OG001
        spread
        24.80
        value
        9.41
    denoms
    1. counts
      1. group Id
        OG000
        value
        302
      2. group Id
        OG001
        value
        329
      units
      Participants
    title
    Change from baseline: Cycle 3, Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.63
        value
        7.48
      2. group Id
        OG001
        spread
        23.57
        value
        3.67
    denoms
    1. counts
      1. group Id
        OG000
        value
        202
      2. group Id
        OG001
        value
        254
      units
      Participants
    title
    Change from baseline: Cycle 4, Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        27.44
        value
        5.70
      2. group Id
        OG001
        spread
        23.27
        value
        -0.95
    denoms
    1. counts
      1. group Id
        OG000
        value
        39
      2. group Id
        OG001
        value
        105
      units
      Participants
    title
    Change from baseline: Cycle 12, Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        28.97
        value
        11.11
      2. group Id
        OG001
        spread
        21.97
        value
        -8.05
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        69
      units
      Participants
    title
    Change from baseline: Cycle 20, Day 1
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.85
        value
        15.56
      2. group Id
        OG001
        spread
        28.42
        value
        -12.28
    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
        28.15
        value
        17.27
      2. group Id
        OG001
        spread
        25.95
        value
        19.60
    denoms
    1. counts
      1. group Id
        OG000
        value
        267
      2. group Id
        OG001
        value
        201
      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: Fatigue Symptom Scale
type
SECONDARY
unit Of Measure
units of a scale

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Preserved source evidence · Not medical advice