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NCT02388906 · OUTCOME

Health Related Quality of Life (HRQoL) Evaluation

Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma · Source last updated 2025-04-24

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

Measure
MEAN
Unit
Scores on a scale
Interval / dispersion
Standard Deviation
Time frame
up to 36 months

What was measured

HRQoL was measured by mean changes from baseline in EORTC-QLQ-C30 global health status/QoL composite scale and in remaining EORTC QLQ-C30 scales in all randomized participants. EORTC QLQ-C30 is the most commonly used QoL instrument in melanoma clinical studies, is a 30-item instrument that has gained wide acceptance in oncology clinical studies and comprises 5 functional scales (physical functioning, cognitive functioning, emotional functioning, social functioning and global quality of life) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Except for the overall health status and global quality of life items, responses for all items are 4 point categorical scales ranging from 1 (Not at all) to 4 (Very much). The overall health status/quality of life responses are 7-point Likert scales for which higher score reflects higher health status/quality of life for the 7-point Likert scale.

Analysis population: All randomized Participants with values from the second follow-up visit

Groups in this outcome

Nivolumab 3 mg/kg

Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24

Ipilimumab 10 mg/kg

Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks

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

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg334
Ipilimumab 10 mg/kg308

Reported measurements

Physical functioning

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg327
Ipilimumab 10 mg/kg307
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Nivolumab 3 mg/kg-2.0415.134Not reportedNot reportedNot reported
Ipilimumab 10 mg/kg-4.8815.713Not reportedNot reportedNot reported
Role functioning

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg329
Ipilimumab 10 mg/kg307
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Nivolumab 3 mg/kg-2.4325.219Not reportedNot reportedNot reported
Ipilimumab 10 mg/kg-3.8529.951Not reportedNot reportedNot reported
Emotional functioning

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg330
Ipilimumab 10 mg/kg307
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Nivolumab 3 mg/kg0.1820.282Not reportedNot reportedNot reported
Ipilimumab 10 mg/kg1.4317.911Not reportedNot reportedNot reported
Cognitive functioning

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg330
Ipilimumab 10 mg/kg307
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Nivolumab 3 mg/kg-3.7418.364Not reportedNot reportedNot reported
Ipilimumab 10 mg/kg-4.6716.664Not reportedNot reportedNot reported
Social functioning

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg330
Ipilimumab 10 mg/kg307
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Nivolumab 3 mg/kg-0.5122.085Not reportedNot reportedNot reported
Ipilimumab 10 mg/kg-3.5326.391Not reportedNot reportedNot reported
Global health status

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg330
Ipilimumab 10 mg/kg307
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Nivolumab 3 mg/kg-5.8120.046Not reportedNot reportedNot reported
Ipilimumab 10 mg/kg-7.0023.109Not reportedNot reportedNot reported
Fatigue

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg329
Ipilimumab 10 mg/kg307
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Nivolumab 3 mg/kg6.4521.605Not reportedNot reportedNot reported
Ipilimumab 10 mg/kg9.0523.475Not reportedNot reportedNot reported
Nausea and vomiting

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg329
Ipilimumab 10 mg/kg307
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Nivolumab 3 mg/kg2.2312.622Not reportedNot reportedNot reported
Ipilimumab 10 mg/kg1.9011.473Not reportedNot reportedNot reported
Pain

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg331
Ipilimumab 10 mg/kg308
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Nivolumab 3 mg/kg1.6623.314Not reportedNot reportedNot reported
Ipilimumab 10 mg/kg4.3823.641Not reportedNot reportedNot reported
Dyspnea

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg328
Ipilimumab 10 mg/kg306
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Nivolumab 3 mg/kg7.3222.741Not reportedNot reportedNot reported
Ipilimumab 10 mg/kg5.4520.364Not reportedNot reportedNot reported
Insomnia

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg329
Ipilimumab 10 mg/kg306
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Nivolumab 3 mg/kg1.8228.692Not reportedNot reportedNot reported
Ipilimumab 10 mg/kg3.0528.785Not reportedNot reportedNot reported
Appetite loss

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg328
Ipilimumab 10 mg/kg307
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Nivolumab 3 mg/kg4.0722.660Not reportedNot reportedNot reported
Ipilimumab 10 mg/kg2.6119.257Not reportedNot reportedNot reported
Constipation

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg329
Ipilimumab 10 mg/kg307
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Nivolumab 3 mg/kg1.1117.904Not reportedNot reportedNot reported
Ipilimumab 10 mg/kg0.3318.373Not reportedNot reportedNot reported
Diarrhea

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg330
Ipilimumab 10 mg/kg306
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Nivolumab 3 mg/kg1.3120.831Not reportedNot reportedNot reported
Ipilimumab 10 mg/kg3.3821.242Not reportedNot reportedNot reported
Financial difficulties

Analysis denominator · Participants

GroupSource count
Nivolumab 3 mg/kg330
Ipilimumab 10 mg/kg306
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Nivolumab 3 mg/kg-1.4123.348Not reportedNot reportedNot reported
Ipilimumab 10 mg/kg0.5420.282Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.134
        value
        -2.04
      2. group Id
        OG001
        spread
        15.713
        value
        -4.88
    denoms
    1. counts
      1. group Id
        OG000
        value
        327
      2. group Id
        OG001
        value
        307
      units
      Participants
    title
    Physical functioning
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.219
        value
        -2.43
      2. group Id
        OG001
        spread
        29.951
        value
        -3.85
    denoms
    1. counts
      1. group Id
        OG000
        value
        329
      2. group Id
        OG001
        value
        307
      units
      Participants
    title
    Role functioning
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.282
        value
        0.18
      2. group Id
        OG001
        spread
        17.911
        value
        1.43
    denoms
    1. counts
      1. group Id
        OG000
        value
        330
      2. group Id
        OG001
        value
        307
      units
      Participants
    title
    Emotional functioning
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.364
        value
        -3.74
      2. group Id
        OG001
        spread
        16.664
        value
        -4.67
    denoms
    1. counts
      1. group Id
        OG000
        value
        330
      2. group Id
        OG001
        value
        307
      units
      Participants
    title
    Cognitive functioning
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.085
        value
        -0.51
      2. group Id
        OG001
        spread
        26.391
        value
        -3.53
    denoms
    1. counts
      1. group Id
        OG000
        value
        330
      2. group Id
        OG001
        value
        307
      units
      Participants
    title
    Social functioning
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.046
        value
        -5.81
      2. group Id
        OG001
        spread
        23.109
        value
        -7.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        330
      2. group Id
        OG001
        value
        307
      units
      Participants
    title
    Global health status
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.605
        value
        6.45
      2. group Id
        OG001
        spread
        23.475
        value
        9.05
    denoms
    1. counts
      1. group Id
        OG000
        value
        329
      2. group Id
        OG001
        value
        307
      units
      Participants
    title
    Fatigue
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.622
        value
        2.23
      2. group Id
        OG001
        spread
        11.473
        value
        1.90
    denoms
    1. counts
      1. group Id
        OG000
        value
        329
      2. group Id
        OG001
        value
        307
      units
      Participants
    title
    Nausea and vomiting
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.314
        value
        1.66
      2. group Id
        OG001
        spread
        23.641
        value
        4.38
    denoms
    1. counts
      1. group Id
        OG000
        value
        331
      2. group Id
        OG001
        value
        308
      units
      Participants
    title
    Pain
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.741
        value
        7.32
      2. group Id
        OG001
        spread
        20.364
        value
        5.45
    denoms
    1. counts
      1. group Id
        OG000
        value
        328
      2. group Id
        OG001
        value
        306
      units
      Participants
    title
    Dyspnea
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        28.692
        value
        1.82
      2. group Id
        OG001
        spread
        28.785
        value
        3.05
    denoms
    1. counts
      1. group Id
        OG000
        value
        329
      2. group Id
        OG001
        value
        306
      units
      Participants
    title
    Insomnia
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.660
        value
        4.07
      2. group Id
        OG001
        spread
        19.257
        value
        2.61
    denoms
    1. counts
      1. group Id
        OG000
        value
        328
      2. group Id
        OG001
        value
        307
      units
      Participants
    title
    Appetite loss
denoms
  1. counts
    1. group Id
      OG000
      value
      334
    2. group Id
      OG001
      value
      308
    units
    Participants
description
HRQoL was measured by mean changes from baseline in EORTC-QLQ-C30 global health status/QoL composite scale and in remaining EORTC QLQ-C30 scales in all randomized participants. EORTC QLQ-C30 is the most commonly used QoL instrument in melanoma clinical studies, is a 30-item instrument that has gained wide acceptance in oncology clinical studies and comprises 5 functional scales (physical functioning, cognitive functioning, emotional functioning, social functioning and global quality of life) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Except for the overall health status and global quality of life items, responses for all items are 4 point categorical scales ranging from 1 (Not at all) to 4 (Very much). The overall health status/quality of life responses are 7-point Likert scales for which higher score reflects higher health status/quality of life for the 7-point Likert scale.
dispersion Type
Standard Deviation
groups
  1. description
    Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24
    id
    OG000
    title
    Nivolumab 3 mg/kg
  2. description
    Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks
    id
    OG001
    title
    Ipilimumab 10 mg/kg
param Type
MEAN
population Description
All randomized Participants with values from the second follow-up visit
reporting Status
POSTED
time Frame
up to 36 months
title
Health Related Quality of Life (HRQoL) Evaluation
type
SECONDARY
unit Of Measure
Scores on a scale

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

Preserved source evidence · Not medical advice