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NCT00094653 · OUTCOME

Change From Baseline in Health-Related Quality of Life (QOL) as Measured by the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Instrument at Week 12

MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma · Source last updated 2011-07-11

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

Measure
LEAST_SQUARES_MEAN
Unit
units on a scale
Interval / dispersion
95% Confidence Interval
Time frame
Baseline (Day 1, Cycle1), Week 12

What was measured

The 30 items were grouped into the following: 1 global QOL scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). All scores were linearly transformed to a 0 to 100 scale. For global QOL and functional items, a higher score represents a better level of functioning (100=best/0=worst). For symptom items, a higher score represents a higher level of symptoms (0=no symptom at all/100=very much severe).

Analysis population: All subjects who received at least 1 dose or any partial dose of study medication. N=number of participants analyzed, n=number of participants with measure at given time points.

Groups in this outcome

Ipilimumab Plus gp100

Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\[288V\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\[210M\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.

Ipilimumab Monotherapy

Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.

gp100

Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\[288V\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\[210M\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.

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

Analysis denominator · Participants

GroupSource count
Ipilimumab Plus gp100381
Ipilimumab Monotherapy131
gp100131

Reported measurements

Global QOL (n=226, 83, 77)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ipilimumab Plus gp100-7.4Not reported-10.4-4.3Not reported
Ipilimumab Monotherapy-8.8Not reported-13.5-4.1Not reported
gp100-10.4Not reported-15.3-5.5Not reported
Physical (n=226 83, 78)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ipilimumab Plus gp100-6.2Not reported-8.9-3.4Not reported
Ipilimumab Monotherapy-5.1Not reported-9.4-0.8Not reported
gp100-10.1Not reported-14.5-5.7Not reported
Role Change (n=226, 83, 78)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ipilimumab Plus gp100-9.3Not reported-13.4-5.3Not reported
Ipilimumab Monotherapy-10.5Not reported-16.8-4.1Not reported
gp100-13.7Not reported-20.2-7.2Not reported
Cognitive (n=226, 83, 78)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ipilimumab Plus gp100-3.1Not reported-5.8-0.3Not reported
Ipilimumab Monotherapy-4.3Not reported-8.60.0Not reported
gp100-3.4Not reported-7.81.0Not reported
Emotional (n=227, 83, 78)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ipilimumab Plus gp100-1.5Not reported-4.21.1Not reported
Ipilimumab Monotherapy-3.6Not reported-7.70.6Not reported
gp100-1.5Not reported-5.82.7Not reported
Social (n=227, 83, 76)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ipilimumab Plus gp100-5.6Not reported-9.2-2.0Not reported
Ipilimumab Monotherapy-7.5Not reported-13.2-1.9Not reported
gp100-4.2Not reported-10.11.8Not reported
Fatigue (n=226, 82, 78)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ipilimumab Plus gp10010.6Not reported7.014.1Not reported
Ipilimumab Monotherapy12.5Not reported7.018.1Not reported
gp10014.5Not reported8.820.2Not reported
Nausea and Vomiting (n=226, 83, 78)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ipilimumab Plus gp1004.6Not reported1.97.3Not reported
Ipilimumab Monotherapy3.1Not reported-1.07.3Not reported
gp1004.4Not reported0.18.7Not reported
Pain (n=227, 83, 78)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ipilimumab Plus gp1005.6Not reported2.09.3Not reported
Ipilimumab Monotherapy7.9Not reported2.213.6Not reported
gp10011.9Not reported6.017.7Not reported
Dyspnea (n=222, 81, 77)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ipilimumab Plus gp1003.5Not reported0.06.9Not reported
Ipilimumab Monotherapy5.3Not reported-0.110.7Not reported
gp1009.1Not reported3.614.6Not reported
Sleep Disturbance (n=225, 83, 76)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ipilimumab Plus gp1006.5Not reported2.310.7Not reported
Ipilimumab Monotherapy10.1Not reported3.616.6Not reported
gp10011.0Not reported4.317.8Not reported
Appetite Loss (n=225, 83, 78)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ipilimumab Plus gp1008.5Not reported4.412.5Not reported
Ipilimumab Monotherapy11.6Not reported5.317.9Not reported
gp10010.3Not reported3.816.8Not reported
Constipation (n=225, 83, 77)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ipilimumab Plus gp1005.2Not reported1.78.7Not reported
Ipilimumab Monotherapy1.9Not reported-3.57.2Not reported
gp10011.8Not reported6.217.4Not reported
Diarrhea (n=223, 82, 78)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ipilimumab Plus gp1006.4Not reported2.810.1Not reported
Ipilimumab Monotherapy9.1Not reported3.414.7Not reported
gp1002.1Not reported-3.77.9Not reported
Financial Impact (n=226, 83, 76)
Values in units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ipilimumab Plus gp1000.0Not reported-3.23.2Not reported
Ipilimumab Monotherapy3.1Not reported-1.98.1Not reported
gp1001.7Not reported-3.56.9Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    -2.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    8.6
    estimate Comment
    Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.
    group Description
    Global quality of life change from baseline
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.2805
    param Type
    Mean Difference (Final Values)
    param Value
    3.0
    statistical Method
    ANCOVA
    tested Non Inferiority
    false
  2. ci Lower Limit
    -5.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    8.2
    estimate Comment
    Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.
    group Description
    Global quality of life change from baseline
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.6300
    param Type
    Mean Difference (Final Values)
    param Value
    1.6
    statistical Method
    ANCOVA
    tested Non Inferiority
    false
  3. ci Lower Limit
    -3.9
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    6.8
    estimate Comment
    Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.
    group Description
    Global quality of life change from baseline
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.6026
    param Type
    Mean Difference (Final Values)
    param Value
    1.4
    statistical Method
    ANCOVA
    tested Non Inferiority
    false
  4. ci Lower Limit
    -1.1
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    8.9
    estimate Comment
    Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.
    group Description
    Physical change from baseline
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.1219
    param Type
    Mean Difference (Final Values)
    param Value
    3.9
    statistical Method
    ANCOVA
    tested Non Inferiority
    false
  5. ci Lower Limit
    -0.9
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    11.0
    estimate Comment
    Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.
    group Description
    Physical change from baseline
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0978
    param Type
    Mean Difference (Final Values)
    param Value
    5.0
    statistical Method
    ANCOVA
    tested Non Inferiority
    false
  6. ci Lower Limit
    -6.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.8
    estimate Comment
    Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.
    group Description
    Physical change from baseline
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.6590
    param Type
    Mean Difference (Final Values)
    param Value
    -1.1
    statistical Method
    ANCOVA
    tested Non Inferiority
    false
  7. ci Lower Limit
    -3.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    11.7
    estimate Comment
    Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.
    group Description
    Role change, change from baseline
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.2480
    param Type
    Mean Difference (Final Values)
    param Value
    4.3
    statistical Method
    ANCOVA
    tested Non Inferiority
    false
  8. ci Lower Limit
    -5.6
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    12.0
    estimate Comment
    Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.
    group Description
    Role change, change from baseline
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.4742
    param Type
    Mean Difference (Final Values)
    param Value
    3.2
    statistical Method
    ANCOVA
    tested Non Inferiority
    false
  9. ci Lower Limit
    -6.1
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    8.3
    estimate Comment
    Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.
    group Description
    Role change, change from baseline
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.7597
    param Type
    Mean Difference (Final Values)
    param Value
    1.1
    statistical Method
    ANCOVA
    tested Non Inferiority
    false
  10. ci Lower Limit
    -4.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.2
    estimate Comment
    Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.
    group Description
    Cognitive change from baseline
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.9119
    param Type
    Mean Difference (Final Values)
    param Value
    0.3
    statistical Method
    ANCOVA
    tested Non Inferiority
    false
  11. ci Lower Limit
    -6.9
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.0
    estimate Comment
    Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.
    group Description
    Cognitive change from baseline
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.7616
    param Type
    Mean Difference (Final Values)
    param Value
    -0.9
    statistical Method
    ANCOVA
    tested Non Inferiority
    false
  12. ci Lower Limit
    -3.6
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    6.0
    estimate Comment
    Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.
    group Description
    Cognitive change from baseline
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.6266
    param Type
    Mean Difference (Final Values)
    param Value
    1.2
    statistical Method
    ANCOVA
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    -2.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    8.6
    estimate Comment
    Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.
    group Description
    Global quality of life change from baseline
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.2805
    param Type
    Mean Difference (Final Values)
    param Value
    3.0
    statistical Method
    ANCOVA
    tested Non Inferiority
    false
  2. ci Lower Limit
    -5.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    8.2
    estimate Comment
    Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.
    group Description
    Global quality of life change from baseline
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.6300
    param Type
    Mean Difference (Final Values)
    param Value
    1.6
    statistical Method
    ANCOVA
    tested Non Inferiority
    false
  3. ci Lower Limit
    -3.9
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    6.8
    estimate Comment
    Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.
    group Description
    Global quality of life change from baseline
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.6026
    param Type
    Mean Difference (Final Values)
    param Value
    1.4
    statistical Method
    ANCOVA
    tested Non Inferiority
    false
  4. ci Lower Limit
    -1.1
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    8.9
    estimate Comment
    Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.
    group Description
    Physical change from baseline
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.1219
    param Type
    Mean Difference (Final Values)
    param Value
    3.9
    statistical Method
    ANCOVA
    tested Non Inferiority
    false
  5. ci Lower Limit
    -0.9
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    11.0
    estimate Comment
    Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.
    group Description
    Physical change from baseline
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0978
    param Type
    Mean Difference (Final Values)
    param Value
    5.0
    statistical Method
    ANCOVA
    tested Non Inferiority
    false
  6. ci Lower Limit
    -6.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.8
    estimate Comment
    Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.
    group Description
    Physical change from baseline
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.6590
    param Type
    Mean Difference (Final Values)
    param Value
    -1.1
    statistical Method
    ANCOVA
    tested Non Inferiority
    false
  7. ci Lower Limit
    -3.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    11.7
    estimate Comment
    Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.
    group Description
    Role change, change from baseline
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.2480
    param Type
    Mean Difference (Final Values)
    param Value
    4.3
    statistical Method
    ANCOVA
    tested Non Inferiority
    false
  8. ci Lower Limit
    -5.6
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    12.0
    estimate Comment
    Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.
    group Description
    Role change, change from baseline
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.4742
    param Type
    Mean Difference (Final Values)
    param Value
    3.2
    statistical Method
    ANCOVA
    tested Non Inferiority
    false
  9. ci Lower Limit
    -6.1
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    8.3
    estimate Comment
    Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.
    group Description
    Role change, change from baseline
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.7597
    param Type
    Mean Difference (Final Values)
    param Value
    1.1
    statistical Method
    ANCOVA
    tested Non Inferiority
    false
  10. ci Lower Limit
    -4.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.2
    estimate Comment
    Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.
    group Description
    Cognitive change from baseline
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.9119
    param Type
    Mean Difference (Final Values)
    param Value
    0.3
    statistical Method
    ANCOVA
    tested Non Inferiority
    false
  11. ci Lower Limit
    -6.9
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.0
    estimate Comment
    Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.
    group Description
    Cognitive change from baseline
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.7616
    param Type
    Mean Difference (Final Values)
    param Value
    -0.9
    statistical Method
    ANCOVA
    tested Non Inferiority
    false
  12. ci Lower Limit
    -3.6
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    6.0
    estimate Comment
    Least square mean can be defined as a linear combination of estimated effects, from a linear model. These means are based on ANCOVA model with covariate variables as baseline score, M-stage and prior-IL2 treatment at randomization, and treatment.
    group Description
    Cognitive change from baseline
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.6266
    param Type
    Mean Difference (Final Values)
    param Value
    1.2
    statistical Method
    ANCOVA
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -10.4
        upper Limit
        -4.3
        value
        -7.4
      2. group Id
        OG001
        lower Limit
        -13.5
        upper Limit
        -4.1
        value
        -8.8
      3. group Id
        OG002
        lower Limit
        -15.3
        upper Limit
        -5.5
        value
        -10.4
    title
    Global QOL (n=226, 83, 77)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -8.9
        upper Limit
        -3.4
        value
        -6.2
      2. group Id
        OG001
        lower Limit
        -9.4
        upper Limit
        -0.8
        value
        -5.1
      3. group Id
        OG002
        lower Limit
        -14.5
        upper Limit
        -5.7
        value
        -10.1
    title
    Physical (n=226 83, 78)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -13.4
        upper Limit
        -5.3
        value
        -9.3
      2. group Id
        OG001
        lower Limit
        -16.8
        upper Limit
        -4.1
        value
        -10.5
      3. group Id
        OG002
        lower Limit
        -20.2
        upper Limit
        -7.2
        value
        -13.7
    title
    Role Change (n=226, 83, 78)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -5.8
        upper Limit
        -0.3
        value
        -3.1
      2. group Id
        OG001
        lower Limit
        -8.6
        upper Limit
        0.0
        value
        -4.3
      3. group Id
        OG002
        lower Limit
        -7.8
        upper Limit
        1.0
        value
        -3.4
    title
    Cognitive (n=226, 83, 78)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -4.2
        upper Limit
        1.1
        value
        -1.5
      2. group Id
        OG001
        lower Limit
        -7.7
        upper Limit
        0.6
        value
        -3.6
      3. group Id
        OG002
        lower Limit
        -5.8
        upper Limit
        2.7
        value
        -1.5
    title
    Emotional (n=227, 83, 78)
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -9.2
        upper Limit
        -2.0
        value
        -5.6
      2. group Id
        OG001
        lower Limit
        -13.2
        upper Limit
        -1.9
        value
        -7.5
      3. group Id
        OG002
        lower Limit
        -10.1
        upper Limit
        1.8
        value
        -4.2
    title
    Social (n=227, 83, 76)
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.0
        upper Limit
        14.1
        value
        10.6
      2. group Id
        OG001
        lower Limit
        7.0
        upper Limit
        18.1
        value
        12.5
      3. group Id
        OG002
        lower Limit
        8.8
        upper Limit
        20.2
        value
        14.5
    title
    Fatigue (n=226, 82, 78)
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.9
        upper Limit
        7.3
        value
        4.6
      2. group Id
        OG001
        lower Limit
        -1.0
        upper Limit
        7.3
        value
        3.1
      3. group Id
        OG002
        lower Limit
        0.1
        upper Limit
        8.7
        value
        4.4
    title
    Nausea and Vomiting (n=226, 83, 78)
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.0
        upper Limit
        9.3
        value
        5.6
      2. group Id
        OG001
        lower Limit
        2.2
        upper Limit
        13.6
        value
        7.9
      3. group Id
        OG002
        lower Limit
        6.0
        upper Limit
        17.7
        value
        11.9
    title
    Pain (n=227, 83, 78)
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        6.9
        value
        3.5
      2. group Id
        OG001
        lower Limit
        -0.1
        upper Limit
        10.7
        value
        5.3
      3. group Id
        OG002
        lower Limit
        3.6
        upper Limit
        14.6
        value
        9.1
    title
    Dyspnea (n=222, 81, 77)
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.3
        upper Limit
        10.7
        value
        6.5
      2. group Id
        OG001
        lower Limit
        3.6
        upper Limit
        16.6
        value
        10.1
      3. group Id
        OG002
        lower Limit
        4.3
        upper Limit
        17.8
        value
        11.0
    title
    Sleep Disturbance (n=225, 83, 76)
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.4
        upper Limit
        12.5
        value
        8.5
      2. group Id
        OG001
        lower Limit
        5.3
        upper Limit
        17.9
        value
        11.6
      3. group Id
        OG002
        lower Limit
        3.8
        upper Limit
        16.8
        value
        10.3
    title
    Appetite Loss (n=225, 83, 78)
denoms
  1. counts
    1. group Id
      OG000
      value
      381
    2. group Id
      OG001
      value
      131
    3. group Id
      OG002
      value
      131
    units
    Participants
description
The 30 items were grouped into the following: 1 global QOL scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). All scores were linearly transformed to a 0 to 100 scale. For global QOL and functional items, a higher score represents a better level of functioning (100=best/0=worst). For symptom items, a higher score represents a higher level of symptoms (0=no symptom at all/100=very much severe).
dispersion Type
95% Confidence Interval
groups
  1. description
    Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\[288V\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\[210M\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
    id
    OG000
    title
    Ipilimumab Plus gp100
  2. description
    Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
    id
    OG001
    title
    Ipilimumab Monotherapy
  3. description
    Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\[288V\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\[210M\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
    id
    OG002
    title
    gp100
param Type
LEAST_SQUARES_MEAN
population Description
All subjects who received at least 1 dose or any partial dose of study medication. N=number of participants analyzed, n=number of participants with measure at given time points.
reporting Status
POSTED
time Frame
Baseline (Day 1, Cycle1), Week 12
title
Change From Baseline in Health-Related Quality of Life (QOL) as Measured by the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Instrument at Week 12
type
SECONDARY
unit Of Measure
units on a scale

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Preserved source evidence · Not medical advice