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NCT03036098 · OUTCOME

Change From Baseline in the European Organization for Research and Treatment of Care Quality-of-Life Questionnaire (EORTC QLQ-C30) Global Health Status Score in All Randomized Participants for Primary Study

Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer · Source last updated 2026-03-06

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
Standard Deviation
Time frame
At Baseline, Week 4, Week 10, Week 16, Week 20, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 108, Week 120, Week 144, Week 156, Week 168, Week 180 and Week 192

What was measured

The EORTC QLQ-C30 is a questionnaire used to assess the quality of life in cancer patients. It includes a global health status score, which is measured on a 4-point Likert scale: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much. Responses are combined and converted to scores ranging from 0 to 100. A high score for global health status or health-related quality of life (HRQoL) indicates a high overall HRQoL.

Analysis population: All Randomized Participants - Primary Study

Groups in this outcome

Treatment 1

Participants received Nivolumab 1 mg/kg plus Ipilimumab 3 mg/kg every three weeks (Q3W) for up to 4 doses followed by Nivolumab monotherapy 480 mg every 4 weeks (Q4W) - Primary Study

Treatment 2

Participants received Standard of Care treatment every three weeks (Q3W) for up to 6 cycles - Primary Study

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

Analysis denominator · Participants

GroupSource count
Treatment 1349
Treatment 2357

Reported measurements

Global Health Status - Baseline

Analysis denominator · Participants

GroupSource count
Treatment 1322
Treatment 2316
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 163.422.55Not reportedNot reportedNot reported
Treatment 259.825.05Not reportedNot reportedNot reported
Global Health Status - Week 4

Analysis denominator · Participants

GroupSource count
Treatment 1244
Treatment 2249
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 1-1.118.28Not reportedNot reportedNot reported
Treatment 22.723.21Not reportedNot reportedNot reported
Global Health Status - Week 10

Analysis denominator · Participants

GroupSource count
Treatment 1159
Treatment 2204
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 1-0.523.73Not reportedNot reportedNot reported
Treatment 23.023.55Not reportedNot reportedNot reported
Global Health Status - Week 16

Analysis denominator · Participants

GroupSource count
Treatment 1117
Treatment 2132
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 13.622.59Not reportedNot reportedNot reported
Treatment 23.124.68Not reportedNot reportedNot reported
Global Health Status - Week 20

Analysis denominator · Participants

GroupSource count
Treatment 1103
Treatment 267
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 12.622.02Not reportedNot reportedNot reported
Treatment 25.124.44Not reportedNot reportedNot reported
Global Health Status - Week 24

Analysis denominator · Participants

GroupSource count
Treatment 1106
Treatment 236
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 11.925.78Not reportedNot reportedNot reported
Treatment 22.526.19Not reportedNot reportedNot reported
Global Health Status - Week 36

Analysis denominator · Participants

GroupSource count
Treatment 189
Treatment 210
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 1-0.922.14Not reportedNot reportedNot reported
Treatment 2-1.728.81Not reportedNot reportedNot reported
Global Health Status - Week 48

Analysis denominator · Participants

GroupSource count
Treatment 162
Treatment 23
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 10.519.72Not reportedNot reportedNot reported
Treatment 22.817.35Not reportedNot reportedNot reported
Global Health Status - Week 60

Analysis denominator · Participants

GroupSource count
Treatment 156
Treatment 20
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 17.624.11Not reportedNot reportedNot reported
Global Health Status - Week 72

Analysis denominator · Participants

GroupSource count
Treatment 147
Treatment 20
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 12.727.04Not reportedNot reportedNot reported
Global Health Status - Week 84

Analysis denominator · Participants

GroupSource count
Treatment 134
Treatment 20
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 18.124.40Not reportedNot reportedNot reported
Global Health Status - Week 96

Analysis denominator · Participants

GroupSource count
Treatment 129
Treatment 20
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 13.226.86Not reportedNot reportedNot reported
Global Health Status - Week 108

Analysis denominator · Participants

GroupSource count
Treatment 116
Treatment 20
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 14.737.51Not reportedNot reportedNot reported
Global Health Status - Week 120

Analysis denominator · Participants

GroupSource count
Treatment 14
Treatment 20
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 1-20.828.46Not reportedNot reportedNot reported
Global Health Status - Week 144

Analysis denominator · Participants

GroupSource count
Treatment 11
Treatment 20
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 1-16.7NANot reportedNot reportedInsufficient number of participants to calculate SD.
Global Health Status - Week 156

Analysis denominator · Participants

GroupSource count
Treatment 11
Treatment 20
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 1-16.7NANot reportedNot reportedInsufficient number of participants to calculate SD.
Global Health Status - Week 168

Analysis denominator · Participants

GroupSource count
Treatment 11
Treatment 20
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 10.0NANot reportedNot reportedInsufficient number of participants to calculate SD.
Global Health Status - Week 180

Analysis denominator · Participants

GroupSource count
Treatment 11
Treatment 20
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 1-8.3NANot reportedNot reportedInsufficient number of participants to calculate SD.
Global Health Status - Week 192

Analysis denominator · Participants

GroupSource count
Treatment 11
Treatment 20
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 1-16.7NANot reportedNot reportedInsufficient number of participants to calculate SD.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.55
        value
        63.4
      2. group Id
        OG001
        spread
        25.05
        value
        59.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        322
      2. group Id
        OG001
        value
        316
      units
      Participants
    title
    Global Health Status - Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.28
        value
        -1.1
      2. group Id
        OG001
        spread
        23.21
        value
        2.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        244
      2. group Id
        OG001
        value
        249
      units
      Participants
    title
    Global Health Status - Week 4
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.73
        value
        -0.5
      2. group Id
        OG001
        spread
        23.55
        value
        3.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        159
      2. group Id
        OG001
        value
        204
      units
      Participants
    title
    Global Health Status - Week 10
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.59
        value
        3.6
      2. group Id
        OG001
        spread
        24.68
        value
        3.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        117
      2. group Id
        OG001
        value
        132
      units
      Participants
    title
    Global Health Status - Week 16
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.02
        value
        2.6
      2. group Id
        OG001
        spread
        24.44
        value
        5.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        103
      2. group Id
        OG001
        value
        67
      units
      Participants
    title
    Global Health Status - Week 20
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.78
        value
        1.9
      2. group Id
        OG001
        spread
        26.19
        value
        2.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        106
      2. group Id
        OG001
        value
        36
      units
      Participants
    title
    Global Health Status - Week 24
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.14
        value
        -0.9
      2. group Id
        OG001
        spread
        28.81
        value
        -1.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        89
      2. group Id
        OG001
        value
        10
      units
      Participants
    title
    Global Health Status - Week 36
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.72
        value
        0.5
      2. group Id
        OG001
        spread
        17.35
        value
        2.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        62
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    Global Health Status - Week 48
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.11
        value
        7.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        56
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Global Health Status - Week 60
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        27.04
        value
        2.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        47
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Global Health Status - Week 72
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.40
        value
        8.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        34
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Global Health Status - Week 84
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        26.86
        value
        3.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        29
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Global Health Status - Week 96
denoms
  1. counts
    1. group Id
      OG000
      value
      349
    2. group Id
      OG001
      value
      357
    units
    Participants
description
The EORTC QLQ-C30 is a questionnaire used to assess the quality of life in cancer patients. It includes a global health status score, which is measured on a 4-point Likert scale: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much. Responses are combined and converted to scores ranging from 0 to 100. A high score for global health status or health-related quality of life (HRQoL) indicates a high overall HRQoL.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received Nivolumab 1 mg/kg plus Ipilimumab 3 mg/kg every three weeks (Q3W) for up to 4 doses followed by Nivolumab monotherapy 480 mg every 4 weeks (Q4W) - Primary Study
    id
    OG000
    title
    Treatment 1
  2. description
    Participants received Standard of Care treatment every three weeks (Q3W) for up to 6 cycles - Primary Study
    id
    OG001
    title
    Treatment 2
param Type
MEAN
population Description
All Randomized Participants - Primary Study
reporting Status
POSTED
time Frame
At Baseline, Week 4, Week 10, Week 16, Week 20, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 108, Week 120, Week 144, Week 156, Week 168, Week 180 and Week 192
title
Change From Baseline in the European Organization for Research and Treatment of Care Quality-of-Life Questionnaire (EORTC QLQ-C30) Global Health Status Score in All Randomized Participants for Primary Study
type
SECONDARY
unit Of Measure
Score on a Scale

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Preserved source evidence · Not medical advice