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NCT03409614 · OUTCOME

Part 1: Change From Baseline in Global Health Status Score as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer · Source last updated 2026-05-18

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
Baseline, Day 1 of 21-Day Cycles 2, 3, 4, 5, 6, 9, 12, 15, 18, 19, 20, 21, 22, 23, 24, 27, 30, 33, 36, 39, 40, 42, 45, 48, 51, 54, 57, 60, 63, 66; Follow-up visit 1 (14 to 30 days after last study treatment) then continued follow-up every 3 months

What was measured

The EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life (QoL) in cancer participants. It consists of 15 domains: 1 Global Health Status (GHS)/QoL scale, 5 functional scales (Physical, role, cognitive, emotional, social), 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). Reported here are the EORTC QLQ-C30 GHS/QoL scores only. GHS/QoL is derived from two items-"How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?"-each scored from 1 (very poor) to 7 (excellent). The average of these two items is linearly transformed to a 0-100 scale; higher scores indicate better overall quality of life, and a positive change from baseline reflects improvement.

Analysis population: Includes only participants in part 1 with both baseline and at least one post-baseline value. Overall number of participants analysed = participants evaluable for the outcome measure. Number analyzed = participants evaluable at the specified timepoint

Groups in this outcome

Part 1: Cemiplimab + Chemotherapy

Participants received cemiplimab plus platinum-based doublet chemotherapy

Part 1: Cemiplimab+AbbrevChemo+Ipilimumab

Participants received cemiplimab plus platinum-based doublet chemotherapy and ipilimumab

Part 1: Chemotherapy

Participants received platinum-based doublet chemotherapy

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

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy97
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab102
Part 1: Chemotherapy91

Reported measurements

Cycle 2, Day 1 (C2D1)

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy94
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab100
Part 1: Chemotherapy91
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy2.1317.237Not reportedNot reportedNot reported
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab1.5815.154Not reportedNot reportedNot reported
Part 1: Chemotherapy0.9214.930Not reportedNot reportedNot reported
C3D1

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy86
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab97
Part 1: Chemotherapy85
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy4.6516.598Not reportedNot reportedNot reported
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab2.7518.310Not reportedNot reportedNot reported
Part 1: Chemotherapy2.1616.525Not reportedNot reportedNot reported
C4D1

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy83
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab89
Part 1: Chemotherapy75
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy6.2216.505Not reportedNot reportedNot reported
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab3.0020.383Not reportedNot reportedNot reported
Part 1: Chemotherapy2.6717.446Not reportedNot reportedNot reported
C5D1

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy78
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab83
Part 1: Chemotherapy52
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy3.3119.385Not reportedNot reportedNot reported
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab4.7218.414Not reportedNot reportedNot reported
Part 1: Chemotherapy0.3218.957Not reportedNot reportedNot reported
C6D1

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy71
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab74
Part 1: Chemotherapy49
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy5.6319.302Not reportedNot reportedNot reported
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab3.3819.356Not reportedNot reportedNot reported
Part 1: Chemotherapy-1.7020.552Not reportedNot reportedNot reported
C9D1

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy57
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab51
Part 1: Chemotherapy11
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy6.8717.965Not reportedNot reportedNot reported
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab1.8022.005Not reportedNot reportedNot reported
Part 1: Chemotherapy-3.7916.399Not reportedNot reportedNot reported
C12D1

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy45
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab41
Part 1: Chemotherapy7
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy4.4422.019Not reportedNot reportedNot reported
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab9.1520.650Not reportedNot reportedNot reported
Part 1: Chemotherapy-3.5713.486Not reportedNot reportedNot reported
C15D1

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy34
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab39
Part 1: Chemotherapy6
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy7.3524.769Not reportedNot reportedNot reported
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab9.4019.325Not reportedNot reportedNot reported
Part 1: Chemotherapy-5.5613.608Not reportedNot reportedNot reported
C18D1

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy26
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab30
Part 1: Chemotherapy5
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy6.7325.606Not reportedNot reportedNot reported
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab14.4420.983Not reportedNot reportedNot reported
Part 1: Chemotherapy-3.3313.944Not reportedNot reportedNot reported
C19D1

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy7
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab8
Part 1: Chemotherapy2
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy22.6220.250Not reportedNot reportedNot reported
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab4.1718.898Not reportedNot reportedNot reported
Part 1: Chemotherapy-16.670.000Not reportedNot reportedNot reported
C20D1

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy6
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab7
Part 1: Chemotherapy2
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy13.8926.176Not reportedNot reportedNot reported
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab9.5212.199Not reportedNot reportedNot reported
Part 1: Chemotherapy-16.670.000Not reportedNot reportedNot reported
C21D1

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy22
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab26
Part 1: Chemotherapy4
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy11.3624.336Not reportedNot reportedNot reported
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab15.7120.592Not reportedNot reportedNot reported
Part 1: Chemotherapy0.0013.608Not reportedNot reportedNot reported
C22D1

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy5
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab7
Part 1: Chemotherapy1
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy20.0029.226Not reportedNot reportedNot reported
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab5.959.272Not reportedNot reportedNot reported
Part 1: Chemotherapy-16.67Not reportedNot reportedNot reportedNot reported
C23D1

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy5
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab4
Part 1: Chemotherapy2
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy11.6726.745Not reportedNot reportedNot reported
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab12.504.811Not reportedNot reportedNot reported
Part 1: Chemotherapy-8.3311.785Not reportedNot reportedNot reported
C24D1

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy18
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab21
Part 1: Chemotherapy3
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy8.3326.040Not reportedNot reportedNot reported
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab14.2923.295Not reportedNot reportedNot reported
Part 1: Chemotherapy-11.119.623Not reportedNot reportedNot reported
C27D1

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy15
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab21
Part 1: Chemotherapy3
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy8.8924.694Not reportedNot reportedNot reported
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab19.0518.285Not reportedNot reportedNot reported
Part 1: Chemotherapy-22.2241.944Not reportedNot reportedNot reported
C30D1

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy16
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab22
Part 1: Chemotherapy3
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy10.9425.408Not reportedNot reportedNot reported
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab13.6417.918Not reportedNot reportedNot reported
Part 1: Chemotherapy-5.5619.245Not reportedNot reportedNot reported
C33D1

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy13
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab20
Part 1: Chemotherapy2
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy12.8219.429Not reportedNot reportedNot reported
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab14.1717.543Not reportedNot reportedNot reported
Part 1: Chemotherapy0.0023.570Not reportedNot reportedNot reported
C36D1

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy8
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab17
Part 1: Chemotherapy1
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy12.5022.713Not reportedNot reportedNot reported
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab13.2417.936Not reportedNot reportedNot reported
Part 1: Chemotherapy16.67Not reportedNot reportedNot reportedNot reported
C39D1

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy1
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab0
Part 1: Chemotherapy1
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy50.00Not reportedNot reportedNot reportedNot reported
Part 1: Chemotherapy16.67Not reportedNot reportedNot reportedNot reported
C40D1

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy1
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab0
Part 1: Chemotherapy0
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy50.00Not reportedNot reportedNot reportedNot reported
C42D1

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy1
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab0
Part 1: Chemotherapy1
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy50.00Not reportedNot reportedNot reportedNot reported
Part 1: Chemotherapy16.67Not reportedNot reportedNot reportedNot reported
C45D1

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy1
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab0
Part 1: Chemotherapy0
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy50.00Not reportedNot reportedNot reportedNot reported
C48D1

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy1
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab0
Part 1: Chemotherapy0
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy50.00Not reportedNot reportedNot reportedNot reported
C51D1

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy1
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab0
Part 1: Chemotherapy0
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy50.00Not reportedNot reportedNot reportedNot reported
C54D1

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy1
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab0
Part 1: Chemotherapy0
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy33.33Not reportedNot reportedNot reportedNot reported
C57D1

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy1
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab0
Part 1: Chemotherapy0
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy33.33Not reportedNot reportedNot reportedNot reported
C60D1

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy1
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab0
Part 1: Chemotherapy0
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy33.33Not reportedNot reportedNot reportedNot reported
C63D1

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy1
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab0
Part 1: Chemotherapy0
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy33.33Not reportedNot reportedNot reportedNot reported
C66D1

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy1
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab0
Part 1: Chemotherapy0
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy41.67Not reportedNot reportedNot reportedNot reported
Follow-up 1

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy35
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab53
Part 1: Chemotherapy56
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy4.0518.455Not reportedNot reportedNot reported
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab3.1421.260Not reportedNot reportedNot reported
Part 1: Chemotherapy3.8720.839Not reportedNot reportedNot reported
Follow-up 2

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy2
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab1
Part 1: Chemotherapy13
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy8.3311.785Not reportedNot reportedNot reported
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab33.33Not reportedNot reportedNot reportedNot reported
Part 1: Chemotherapy3.2122.704Not reportedNot reportedNot reported
Follow-up 3

Analysis denominator · Participants

GroupSource count
Part 1: Cemiplimab + Chemotherapy1
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab0
Part 1: Chemotherapy2
Values in Score on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: Cemiplimab + Chemotherapy-8.33Not reportedNot reportedNot reportedNot reported
Part 1: Chemotherapy4.175.893Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.237
        value
        2.13
      2. group Id
        OG001
        spread
        15.154
        value
        1.58
      3. group Id
        OG002
        spread
        14.930
        value
        0.92
    denoms
    1. counts
      1. group Id
        OG000
        value
        94
      2. group Id
        OG001
        value
        100
      3. group Id
        OG002
        value
        91
      units
      Participants
    title
    Cycle 2, Day 1 (C2D1)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.598
        value
        4.65
      2. group Id
        OG001
        spread
        18.310
        value
        2.75
      3. group Id
        OG002
        spread
        16.525
        value
        2.16
    denoms
    1. counts
      1. group Id
        OG000
        value
        86
      2. group Id
        OG001
        value
        97
      3. group Id
        OG002
        value
        85
      units
      Participants
    title
    C3D1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.505
        value
        6.22
      2. group Id
        OG001
        spread
        20.383
        value
        3.00
      3. group Id
        OG002
        spread
        17.446
        value
        2.67
    denoms
    1. counts
      1. group Id
        OG000
        value
        83
      2. group Id
        OG001
        value
        89
      3. group Id
        OG002
        value
        75
      units
      Participants
    title
    C4D1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.385
        value
        3.31
      2. group Id
        OG001
        spread
        18.414
        value
        4.72
      3. group Id
        OG002
        spread
        18.957
        value
        0.32
    denoms
    1. counts
      1. group Id
        OG000
        value
        78
      2. group Id
        OG001
        value
        83
      3. group Id
        OG002
        value
        52
      units
      Participants
    title
    C5D1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.302
        value
        5.63
      2. group Id
        OG001
        spread
        19.356
        value
        3.38
      3. group Id
        OG002
        spread
        20.552
        value
        -1.70
    denoms
    1. counts
      1. group Id
        OG000
        value
        71
      2. group Id
        OG001
        value
        74
      3. group Id
        OG002
        value
        49
      units
      Participants
    title
    C6D1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.965
        value
        6.87
      2. group Id
        OG001
        spread
        22.005
        value
        1.80
      3. group Id
        OG002
        spread
        16.399
        value
        -3.79
    denoms
    1. counts
      1. group Id
        OG000
        value
        57
      2. group Id
        OG001
        value
        51
      3. group Id
        OG002
        value
        11
      units
      Participants
    title
    C9D1
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.019
        value
        4.44
      2. group Id
        OG001
        spread
        20.650
        value
        9.15
      3. group Id
        OG002
        spread
        13.486
        value
        -3.57
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      2. group Id
        OG001
        value
        41
      3. group Id
        OG002
        value
        7
      units
      Participants
    title
    C12D1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.769
        value
        7.35
      2. group Id
        OG001
        spread
        19.325
        value
        9.40
      3. group Id
        OG002
        spread
        13.608
        value
        -5.56
    denoms
    1. counts
      1. group Id
        OG000
        value
        34
      2. group Id
        OG001
        value
        39
      3. group Id
        OG002
        value
        6
      units
      Participants
    title
    C15D1
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.606
        value
        6.73
      2. group Id
        OG001
        spread
        20.983
        value
        14.44
      3. group Id
        OG002
        spread
        13.944
        value
        -3.33
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        30
      3. group Id
        OG002
        value
        5
      units
      Participants
    title
    C18D1
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.250
        value
        22.62
      2. group Id
        OG001
        spread
        18.898
        value
        4.17
      3. group Id
        OG002
        spread
        0.000
        value
        -16.67
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        2
      units
      Participants
    title
    C19D1
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        26.176
        value
        13.89
      2. group Id
        OG001
        spread
        12.199
        value
        9.52
      3. group Id
        OG002
        spread
        0.000
        value
        -16.67
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        2
      units
      Participants
    title
    C20D1
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.336
        value
        11.36
      2. group Id
        OG001
        spread
        20.592
        value
        15.71
      3. group Id
        OG002
        spread
        13.608
        value
        0.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        26
      3. group Id
        OG002
        value
        4
      units
      Participants
    title
    C21D1
denoms
  1. counts
    1. group Id
      OG000
      value
      97
    2. group Id
      OG001
      value
      102
    3. group Id
      OG002
      value
      91
    units
    Participants
description
The EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life (QoL) in cancer participants. It consists of 15 domains: 1 Global Health Status (GHS)/QoL scale, 5 functional scales (Physical, role, cognitive, emotional, social), 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). Reported here are the EORTC QLQ-C30 GHS/QoL scores only. GHS/QoL is derived from two items-"How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?"-each scored from 1 (very poor) to 7 (excellent). The average of these two items is linearly transformed to a 0-100 scale; higher scores indicate better overall quality of life, and a positive change from baseline reflects improvement.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received cemiplimab plus platinum-based doublet chemotherapy
    id
    OG000
    title
    Part 1: Cemiplimab + Chemotherapy
  2. description
    Participants received cemiplimab plus platinum-based doublet chemotherapy and ipilimumab
    id
    OG001
    title
    Part 1: Cemiplimab+AbbrevChemo+Ipilimumab
  3. description
    Participants received platinum-based doublet chemotherapy
    id
    OG002
    title
    Part 1: Chemotherapy
param Type
MEAN
population Description
Includes only participants in part 1 with both baseline and at least one post-baseline value. Overall number of participants analysed = participants evaluable for the outcome measure. Number analyzed = participants evaluable at the specified timepoint
reporting Status
POSTED
time Frame
Baseline, Day 1 of 21-Day Cycles 2, 3, 4, 5, 6, 9, 12, 15, 18, 19, 20, 21, 22, 23, 24, 27, 30, 33, 36, 39, 40, 42, 45, 48, 51, 54, 57, 60, 63, 66; Follow-up visit 1 (14 to 30 days after last study treatment) then continued follow-up every 3 months
title
Part 1: Change From Baseline in Global Health Status Score as Measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
type
SECONDARY
unit Of Measure
Score on a Scale

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