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NCT03052608 · OUTCOME

Change From Baseline in Global Quality of Life (QOL), Functional Scales and Symptoms Scales as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) During Overall Treatment

A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC · Source last updated 2025-11-25

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

Measure
MEAN
Unit
Units on a scale
Interval / dispersion
95% Confidence Interval
Time frame
From Baseline up to Cycle 38 Day 1

What was measured

The EORTC QLQ C30 consists of 30 questions and includes 5 functional scales (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale; 3 symptom scales (fatigue, pain, nausea and vomiting); and 6 single items that assess additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and financial impact. All scales and single item measures range in score from 0 to 100. Higher scores on the functional scales represent higher levels of functioning. Higher scores on the global health status/quality of life scale represent higher health status/quality of life. Higher scores on symptom scales/items represent a greater presence of symptoms.

Analysis population: Participants from the FA population who completed a baseline (last patient-reported outcome (PRO) assessment prior to the first dose of study treatment) and at least 1 post-baseline PRO assessment.

Groups in this outcome

Lorlatinib

Lorlatinib monotherapy at the recommended Phase 2 dose of 100 mg, was administered orally once daily (QD) at approximately the same time of the day on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.

Crizotinib

Crizotinib monotherapy at the registered dose of 250 mg, was administered orally twice daily (BID) at approximately the same time in the morning and evening (12 hours apart) on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.

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

Analysis denominator · Participants

GroupSource count
Lorlatinib148
Crizotinib140

Reported measurements

Global QOL
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lorlatinib8.60Not reported6.0911.11Not reported
Crizotinib3.95Not reported1.156.76Not reported
Physical Functioning
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lorlatinib4.84Not reported2.677.01Not reported
Crizotinib2.82Not reported0.425.22Not reported
Role Functioning
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lorlatinib6.86Not reported4.059.68Not reported
Crizotinib4.78Not reported1.617.95Not reported
Emotional Functioning
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lorlatinib8.77Not reported6.8810.67Not reported
Crizotinib6.20Not reported4.098.30Not reported
Cognitive Functioning
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lorlatinib-4.20Not reported-6.56-1.84Not reported
Crizotinib-1.02Not reported-3.641.60Not reported
Social Functioning
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lorlatinib7.00Not reported4.489.52Not reported
Crizotinib4.72Not reported1.877.57Not reported
Fatigue
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lorlatinib-9.93Not reported-12.61-7.26Not reported
Crizotinib-4.26Not reported-7.28-1.25Not reported
Nausea and Vomiting
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lorlatinib-4.35Not reported-5.79-2.90Not reported
Crizotinib3.51Not reported1.895.14Not reported
Pain
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lorlatinib-4.60Not reported-7.17-2.02Not reported
Crizotinib-5.76Not reported-8.67-2.85Not reported
Dyspnoea
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lorlatinib-7.02Not reported-9.66-4.39Not reported
Crizotinib-8.75Not reported-11.76-5.74Not reported
Insomnia
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lorlatinib-17.34Not reported-19.71-14.96Not reported
Crizotinib-9.39Not reported-12.07-6.71Not reported
Appetite Loss
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lorlatinib-13.15Not reported-15.00-11.30Not reported
Crizotinib-3.95Not reported-6.01-1.88Not reported
Constipation
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lorlatinib-2.40Not reported-5.330.54Not reported
Crizotinib2.53Not reported-0.835.90Not reported
Diarrhea
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lorlatinib-0.92Not reported-3.421.59Not reported
Crizotinib11.12Not reported8.3313.91Not reported
Financial Difficulties
Values in Units on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lorlatinib-6.79Not reported-9.52-4.05Not reported
Crizotinib-5.74Not reported-8.80-2.68Not reported

Source statistical analyses

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

  1. ci Lower Limit
    1.14
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    8.16
    group Description
    This is the analysis for QLQ-C30 Global QOL. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0096
    param Type
    Mean Difference (Net)
    param Value
    4.65
    statistical Method
    Mixed Models Analysis
  2. ci Lower Limit
    -1.01
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.05
    group Description
    This is the analysis for QLQ-C30 Physical Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.1897
    param Type
    Mean Difference (Net)
    param Value
    2.02
    statistical Method
    Mixed Models Analysis
  3. ci Lower Limit
    -1.87
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    6.04
    group Description
    This is the analysis for QLQ-C30 Role Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2999
    param Type
    Mean Difference (Net)
    param Value
    2.09
    statistical Method
    Mixed Models Analysis
  4. ci Lower Limit
    -0.06
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.22
    group Description
    This is the analysis for QLQ-C30 Emotional Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0553
    param Type
    Mean Difference (Net)
    param Value
    2.58
    statistical Method
    Mixed Models Analysis
  5. ci Lower Limit
    -6.47
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.12
    group Description
    This is the analysis for QLQ-C30 Cognitive Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0588
    param Type
    Mean Difference (Net)
    param Value
    -3.18
    statistical Method
    Mixed Models Analysis
  6. ci Lower Limit
    -1.30
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.85
    group Description
    This is the analysis for QLQ-C30 Social Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2118
    param Type
    Mean Difference (Net)
    param Value
    2.27
    statistical Method
    Mixed Models Analysis
  7. ci Lower Limit
    -9.42
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -1.92
    group Description
    This is the analysis for QLQ-C30 Fatigue. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0032
    param Type
    Mean Difference (Net)
    param Value
    -5.67
    statistical Method
    Mixed Models Analysis
  8. ci Lower Limit
    -9.86
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -5.86
    group Description
    This is the analysis for QLQ-C30 Nausea and Vomiting. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Mean Difference (Net)
    param Value
    -7.86
    statistical Method
    Mixed Models Analysis
  9. ci Lower Limit
    -2.49
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.82
    group Description
    This is the analysis for QLQ-C30 Pain. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.5310
    param Type
    Mean Difference (Net)
    param Value
    1.16
    statistical Method
    Mixed Models Analysis
  10. ci Lower Limit
    -1.98
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.43
    group Description
    This is the analysis for QLQ-C30 Dyspnoea. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.3602
    param Type
    Mean Difference (Net)
    param Value
    1.72
    statistical Method
    Mixed Models Analysis
  11. ci Lower Limit
    -11.25
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -4.64
    group Description
    This is the analysis for QLQ-C30 Insomnia. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Mean Difference (Net)
    param Value
    -7.95
    statistical Method
    Mixed Models Analysis
  12. ci Lower Limit
    -11.80
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -6.62
    group Description
    This is the analysis for QLQ-C30 Appetite Loss. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Mean Difference (Net)
    param Value
    -9.21
    statistical Method
    Mixed Models Analysis
Complete source fields
analyses
  1. ci Lower Limit
    1.14
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    8.16
    group Description
    This is the analysis for QLQ-C30 Global QOL. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0096
    param Type
    Mean Difference (Net)
    param Value
    4.65
    statistical Method
    Mixed Models Analysis
  2. ci Lower Limit
    -1.01
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.05
    group Description
    This is the analysis for QLQ-C30 Physical Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.1897
    param Type
    Mean Difference (Net)
    param Value
    2.02
    statistical Method
    Mixed Models Analysis
  3. ci Lower Limit
    -1.87
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    6.04
    group Description
    This is the analysis for QLQ-C30 Role Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2999
    param Type
    Mean Difference (Net)
    param Value
    2.09
    statistical Method
    Mixed Models Analysis
  4. ci Lower Limit
    -0.06
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.22
    group Description
    This is the analysis for QLQ-C30 Emotional Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0553
    param Type
    Mean Difference (Net)
    param Value
    2.58
    statistical Method
    Mixed Models Analysis
  5. ci Lower Limit
    -6.47
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.12
    group Description
    This is the analysis for QLQ-C30 Cognitive Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0588
    param Type
    Mean Difference (Net)
    param Value
    -3.18
    statistical Method
    Mixed Models Analysis
  6. ci Lower Limit
    -1.30
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.85
    group Description
    This is the analysis for QLQ-C30 Social Functioning. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2118
    param Type
    Mean Difference (Net)
    param Value
    2.27
    statistical Method
    Mixed Models Analysis
  7. ci Lower Limit
    -9.42
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -1.92
    group Description
    This is the analysis for QLQ-C30 Fatigue. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0032
    param Type
    Mean Difference (Net)
    param Value
    -5.67
    statistical Method
    Mixed Models Analysis
  8. ci Lower Limit
    -9.86
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -5.86
    group Description
    This is the analysis for QLQ-C30 Nausea and Vomiting. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Mean Difference (Net)
    param Value
    -7.86
    statistical Method
    Mixed Models Analysis
  9. ci Lower Limit
    -2.49
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.82
    group Description
    This is the analysis for QLQ-C30 Pain. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.5310
    param Type
    Mean Difference (Net)
    param Value
    1.16
    statistical Method
    Mixed Models Analysis
  10. ci Lower Limit
    -1.98
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.43
    group Description
    This is the analysis for QLQ-C30 Dyspnoea. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.3602
    param Type
    Mean Difference (Net)
    param Value
    1.72
    statistical Method
    Mixed Models Analysis
  11. ci Lower Limit
    -11.25
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -4.64
    group Description
    This is the analysis for QLQ-C30 Insomnia. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Mean Difference (Net)
    param Value
    -7.95
    statistical Method
    Mixed Models Analysis
  12. ci Lower Limit
    -11.80
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -6.62
    group Description
    This is the analysis for QLQ-C30 Appetite Loss. Estimated change from baseline was based on random intercept random slope mixed-effects model with an intercept term, treatment, time (as a continuous variable), treatment-by-time, baseline and randomization stratification factors as covariates.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Mean Difference (Net)
    param Value
    -9.21
    statistical Method
    Mixed Models Analysis
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.09
        upper Limit
        11.11
        value
        8.60
      2. group Id
        OG001
        lower Limit
        1.15
        upper Limit
        6.76
        value
        3.95
    title
    Global QOL
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.67
        upper Limit
        7.01
        value
        4.84
      2. group Id
        OG001
        lower Limit
        0.42
        upper Limit
        5.22
        value
        2.82
    title
    Physical Functioning
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.05
        upper Limit
        9.68
        value
        6.86
      2. group Id
        OG001
        lower Limit
        1.61
        upper Limit
        7.95
        value
        4.78
    title
    Role Functioning
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.88
        upper Limit
        10.67
        value
        8.77
      2. group Id
        OG001
        lower Limit
        4.09
        upper Limit
        8.30
        value
        6.20
    title
    Emotional Functioning
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -6.56
        upper Limit
        -1.84
        value
        -4.20
      2. group Id
        OG001
        lower Limit
        -3.64
        upper Limit
        1.60
        value
        -1.02
    title
    Cognitive Functioning
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.48
        upper Limit
        9.52
        value
        7.00
      2. group Id
        OG001
        lower Limit
        1.87
        upper Limit
        7.57
        value
        4.72
    title
    Social Functioning
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -12.61
        upper Limit
        -7.26
        value
        -9.93
      2. group Id
        OG001
        lower Limit
        -7.28
        upper Limit
        -1.25
        value
        -4.26
    title
    Fatigue
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -5.79
        upper Limit
        -2.90
        value
        -4.35
      2. group Id
        OG001
        lower Limit
        1.89
        upper Limit
        5.14
        value
        3.51
    title
    Nausea and Vomiting
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -7.17
        upper Limit
        -2.02
        value
        -4.60
      2. group Id
        OG001
        lower Limit
        -8.67
        upper Limit
        -2.85
        value
        -5.76
    title
    Pain
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -9.66
        upper Limit
        -4.39
        value
        -7.02
      2. group Id
        OG001
        lower Limit
        -11.76
        upper Limit
        -5.74
        value
        -8.75
    title
    Dyspnoea
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -19.71
        upper Limit
        -14.96
        value
        -17.34
      2. group Id
        OG001
        lower Limit
        -12.07
        upper Limit
        -6.71
        value
        -9.39
    title
    Insomnia
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -15.00
        upper Limit
        -11.30
        value
        -13.15
      2. group Id
        OG001
        lower Limit
        -6.01
        upper Limit
        -1.88
        value
        -3.95
    title
    Appetite Loss
denoms
  1. counts
    1. group Id
      OG000
      value
      148
    2. group Id
      OG001
      value
      140
    units
    Participants
description
The EORTC QLQ C30 consists of 30 questions and includes 5 functional scales (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale; 3 symptom scales (fatigue, pain, nausea and vomiting); and 6 single items that assess additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and financial impact. All scales and single item measures range in score from 0 to 100. Higher scores on the functional scales represent higher levels of functioning. Higher scores on the global health status/quality of life scale represent higher health status/quality of life. Higher scores on symptom scales/items represent a greater presence of symptoms.
dispersion Type
95% Confidence Interval
groups
  1. description
    Lorlatinib monotherapy at the recommended Phase 2 dose of 100 mg, was administered orally once daily (QD) at approximately the same time of the day on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
    id
    OG000
    title
    Lorlatinib
  2. description
    Crizotinib monotherapy at the registered dose of 250 mg, was administered orally twice daily (BID) at approximately the same time in the morning and evening (12 hours apart) on a continuous daily dosing schedule. Each treatment cycle was defined as 28 days. Treatment continued until confirmation of RECIST version 1.1 defined disease progression assessed by the blinded independent central review (unless clinical benefit was still achievable), participant refusal, participant lost to follow-up, unacceptable toxicity, death, or the study was terminated by the sponsor, whichever occurred first.
    id
    OG001
    title
    Crizotinib
param Type
MEAN
population Description
Participants from the FA population who completed a baseline (last patient-reported outcome (PRO) assessment prior to the first dose of study treatment) and at least 1 post-baseline PRO assessment.
reporting Status
POSTED
time Frame
From Baseline up to Cycle 38 Day 1
title
Change From Baseline in Global Quality of Life (QOL), Functional Scales and Symptoms Scales as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30) During Overall Treatment
type
SECONDARY
unit Of Measure
Units on a scale

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Preserved source evidence · Not medical advice