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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 for Sub-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, and Week 120

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 - Sub-study

Groups in this outcome

Treatment 3

Participants received Nivolumab 360 mg in combination with Standard of Care treatment every 3 weeks (Q3W) for up to 6 cycles followed by Nivolumab monotherapy 480 mg every 4 weeks (Q4W) - Sub-study

Treatment 4

Participants received Standard of Care treatment every three weeks (Q3W) for up to 6 cycles - Sub-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 3304
Treatment 4304

Reported measurements

Global Health Status - Baseline

Analysis denominator · Participants

GroupSource count
Treatment 3291
Treatment 4274
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 366.622.7Not reportedNot reportedNot reported
Treatment 466.822.5Not reportedNot reportedNot reported
Global Health Status - Week 4

Analysis denominator · Participants

GroupSource count
Treatment 3245
Treatment 4218
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 3-0.222.2Not reportedNot reportedNot reported
Treatment 42.017.8Not reportedNot reportedNot reported
Global Health Status - Week 10

Analysis denominator · Participants

GroupSource count
Treatment 3238
Treatment 4187
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 32.924.2Not reportedNot reportedNot reported
Treatment 41.120.6Not reportedNot reportedNot reported
Global Health Status - Week 16

Analysis denominator · Participants

GroupSource count
Treatment 3106
Treatment 4135
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 31.823.1Not reportedNot reportedNot reported
Treatment 4-1.023.7Not reportedNot reportedNot reported
Global Health Status - Week 20

Analysis denominator · Participants

GroupSource count
Treatment 3165
Treatment 450
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 34.324.6Not reportedNot reportedNot reported
Treatment 4-0.522.8Not reportedNot reportedNot reported
Global Health Status - Week 24

Analysis denominator · Participants

GroupSource count
Treatment 3193
Treatment 429
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 34.025.3Not reportedNot reportedNot reported
Treatment 4-0.613.0Not reportedNot reportedNot reported
Global Health Status - Week 36

Analysis denominator · Participants

GroupSource count
Treatment 3150
Treatment 49
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 36.425.1Not reportedNot reportedNot reported
Treatment 4-3.717.2Not reportedNot reportedNot reported
Global Health Status - Week 48

Analysis denominator · Participants

GroupSource count
Treatment 392
Treatment 43
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 37.124.9Not reportedNot reportedNot reported
Treatment 4-2.812.7Not reportedNot reportedNot reported
Global Health Status - Week 60

Analysis denominator · Participants

GroupSource count
Treatment 362
Treatment 40
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 38.125.0Not reportedNot reportedNot reported
Global Health Status - Week 72

Analysis denominator · Participants

GroupSource count
Treatment 354
Treatment 41
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 36.626.5Not reportedNot reportedNot reported
Treatment 4-8.3NANot reportedNot reportedInsufficient number of participants to calculate SD.
Global Health Status - Week 84

Analysis denominator · Participants

GroupSource count
Treatment 339
Treatment 40
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 39.826.7Not reportedNot reportedNot reported
Global Health Status - Week 96

Analysis denominator · Participants

GroupSource count
Treatment 326
Treatment 40
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 39.018.2Not reportedNot reportedNot reported
Global Health Status - Week 108

Analysis denominator · Participants

GroupSource count
Treatment 311
Treatment 40
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 37.613.7Not reportedNot reportedNot reported
Global Health Status - Week 120

Analysis denominator · Participants

GroupSource count
Treatment 33
Treatment 40
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Treatment 313.925.5Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.7
        value
        66.6
      2. group Id
        OG001
        spread
        22.5
        value
        66.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        291
      2. group Id
        OG001
        value
        274
      units
      Participants
    title
    Global Health Status - Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.2
        value
        -0.2
      2. group Id
        OG001
        spread
        17.8
        value
        2.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        245
      2. group Id
        OG001
        value
        218
      units
      Participants
    title
    Global Health Status - Week 4
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.2
        value
        2.9
      2. group Id
        OG001
        spread
        20.6
        value
        1.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        238
      2. group Id
        OG001
        value
        187
      units
      Participants
    title
    Global Health Status - Week 10
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.1
        value
        1.8
      2. group Id
        OG001
        spread
        23.7
        value
        -1.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        106
      2. group Id
        OG001
        value
        135
      units
      Participants
    title
    Global Health Status - Week 16
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.6
        value
        4.3
      2. group Id
        OG001
        spread
        22.8
        value
        -0.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        165
      2. group Id
        OG001
        value
        50
      units
      Participants
    title
    Global Health Status - Week 20
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.3
        value
        4.0
      2. group Id
        OG001
        spread
        13.0
        value
        -0.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        193
      2. group Id
        OG001
        value
        29
      units
      Participants
    title
    Global Health Status - Week 24
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.1
        value
        6.4
      2. group Id
        OG001
        spread
        17.2
        value
        -3.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        150
      2. group Id
        OG001
        value
        9
      units
      Participants
    title
    Global Health Status - Week 36
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.9
        value
        7.1
      2. group Id
        OG001
        spread
        12.7
        value
        -2.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        92
      2. group Id
        OG001
        value
        3
      units
      Participants
    title
    Global Health Status - Week 48
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.0
        value
        8.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        62
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Global Health Status - Week 60
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        26.5
        value
        6.6
      2. comment
        Insufficient number of participants to calculate SD.
        group Id
        OG001
        spread
        NA
        value
        -8.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        54
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    Global Health Status - Week 72
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        26.7
        value
        9.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        39
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Global Health Status - Week 84
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.2
        value
        9.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        0
      units
      Participants
    title
    Global Health Status - Week 96
denoms
  1. counts
    1. group Id
      OG000
      value
      304
    2. group Id
      OG001
      value
      304
    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 360 mg in combination with Standard of Care treatment every 3 weeks (Q3W) for up to 6 cycles followed by Nivolumab monotherapy 480 mg every 4 weeks (Q4W) - Sub-study
    id
    OG000
    title
    Treatment 3
  2. description
    Participants received Standard of Care treatment every three weeks (Q3W) for up to 6 cycles - Sub-study
    id
    OG001
    title
    Treatment 4
param Type
MEAN
population Description
All Randomized Participants - Sub-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, and Week 120
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 for Sub-study
type
SECONDARY
unit Of Measure
Score on a Scale

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

Preserved source evidence · Not medical advice