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NCT01828099 · OUTCOME

Least Squares Mean Scores on the EORTC QLQ- LC13

LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer · Source last updated 2025-01-16

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

Measure
LEAST_SQUARES_MEAN
Unit
Score on a scale
Interval / dispersion
Standard Error
Time frame
Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months

What was measured

The EORTC QLQ-LC13 was used in conjunction with the EORTC QLQ-C30 and provided information on an additional 13 items specifically related to lung cancer. The lung cancer module incorporated one multi-item scale to assess dyspnea, and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. Items were scored on a 4-point Likert scale ranging from 1="not at all" to 4="very much". For the multi-item scale, the scores were averaged from the scores of the component items, transformed, and then analyzed on a 0 - 100 scale. For the single item scale, raw scores were transformed and analyzed on a 0-100 scale. A high score indicated a high level of symptoms The scores were analyzed using repeated measurement model for longitudinal data, including terms for visit, treatment, treatment by time interaction, strata and baseline score. Overall mean and standard error were obtained.

Analysis population: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Participants with a baseline assessment for at least one of the domain scores

Groups in this outcome

Ceritinib

Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state

Chemotherapy

Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance)

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

Analysis denominator · Participants

GroupSource count
Ceritinib181
Chemotherapy159

Reported measurements

Dyspnoea

Analysis denominator · Participants

GroupSource count
Ceritinib181
Chemotherapy158
Values in Score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Ceritinib16.20.74Not reportedNot reportedNot reported
Chemotherapy23.31.02Not reportedNot reportedNot reported
Pain in chest

Analysis denominator · Participants

GroupSource count
Ceritinib181
Chemotherapy159
Values in Score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Ceritinib9.40.59Not reportedNot reportedNot reported
Chemotherapy11.80.82Not reportedNot reportedNot reported
Pain in Arm or Shoulder

Analysis denominator · Participants

GroupSource count
Ceritinib181
Chemotherapy157
Values in Score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Ceritinib10.60.69Not reportedNot reportedNot reported
Chemotherapy12.30.97Not reportedNot reportedNot reported
Pain in Other Parts

Analysis denominator · Participants

GroupSource count
Ceritinib180
Chemotherapy157
Values in Score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Ceritinib12.50.71Not reportedNot reportedNot reported
Chemotherapy15.01.01Not reportedNot reportedNot reported
Coughing

Analysis denominator · Participants

GroupSource count
Ceritinib181
Chemotherapy159
Values in Score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Ceritinib14.70.63Not reportedNot reportedNot reported
Chemotherapy23.00.88Not reportedNot reportedNot reported
Sore Mouth

Analysis denominator · Participants

GroupSource count
Ceritinib181
Chemotherapy159
Values in Score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Ceritinib3.00.35Not reportedNot reportedNot reported
Chemotherapy6.80.49Not reportedNot reportedNot reported
Dysphagia

Analysis denominator · Participants

GroupSource count
Ceritinib181
Chemotherapy159
Values in Score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Ceritinib4.10.37Not reportedNot reportedNot reported
Chemotherapy5.50.52Not reportedNot reportedNot reported
Peripheral Neuropathy

Analysis denominator · Participants

GroupSource count
Ceritinib181
Chemotherapy159
Values in Score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Ceritinib9.70.69Not reportedNot reportedNot reported
Chemotherapy16.00.96Not reportedNot reportedNot reported
Alopecia

Analysis denominator · Participants

GroupSource count
Ceritinib181
Chemotherapy159
Values in Score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Ceritinib6.80.70Not reportedNot reportedNot reported
Chemotherapy13.30.95Not reportedNot reportedNot reported
Haemoptysis

Analysis denominator · Participants

GroupSource count
Ceritinib181
Chemotherapy159
Values in Score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Ceritinib0.70.18Not reportedNot reportedNot reported
Chemotherapy1.50.25Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.74
        value
        16.2
      2. group Id
        OG001
        spread
        1.02
        value
        23.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        181
      2. group Id
        OG001
        value
        158
      units
      Participants
    title
    Dyspnoea
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.59
        value
        9.4
      2. group Id
        OG001
        spread
        0.82
        value
        11.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        181
      2. group Id
        OG001
        value
        159
      units
      Participants
    title
    Pain in chest
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.69
        value
        10.6
      2. group Id
        OG001
        spread
        0.97
        value
        12.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        181
      2. group Id
        OG001
        value
        157
      units
      Participants
    title
    Pain in Arm or Shoulder
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.71
        value
        12.5
      2. group Id
        OG001
        spread
        1.01
        value
        15.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        180
      2. group Id
        OG001
        value
        157
      units
      Participants
    title
    Pain in Other Parts
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.63
        value
        14.7
      2. group Id
        OG001
        spread
        0.88
        value
        23.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        181
      2. group Id
        OG001
        value
        159
      units
      Participants
    title
    Coughing
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.35
        value
        3.0
      2. group Id
        OG001
        spread
        0.49
        value
        6.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        181
      2. group Id
        OG001
        value
        159
      units
      Participants
    title
    Sore Mouth
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.37
        value
        4.1
      2. group Id
        OG001
        spread
        0.52
        value
        5.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        181
      2. group Id
        OG001
        value
        159
      units
      Participants
    title
    Dysphagia
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.69
        value
        9.7
      2. group Id
        OG001
        spread
        0.96
        value
        16.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        181
      2. group Id
        OG001
        value
        159
      units
      Participants
    title
    Peripheral Neuropathy
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.70
        value
        6.8
      2. group Id
        OG001
        spread
        0.95
        value
        13.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        181
      2. group Id
        OG001
        value
        159
      units
      Participants
    title
    Alopecia
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.18
        value
        0.7
      2. group Id
        OG001
        spread
        0.25
        value
        1.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        181
      2. group Id
        OG001
        value
        159
      units
      Participants
    title
    Haemoptysis
denoms
  1. counts
    1. group Id
      OG000
      value
      181
    2. group Id
      OG001
      value
      159
    units
    Participants
description
The EORTC QLQ-LC13 was used in conjunction with the EORTC QLQ-C30 and provided information on an additional 13 items specifically related to lung cancer. The lung cancer module incorporated one multi-item scale to assess dyspnea, and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. Items were scored on a 4-point Likert scale ranging from 1="not at all" to 4="very much". For the multi-item scale, the scores were averaged from the scores of the component items, transformed, and then analyzed on a 0 - 100 scale. For the single item scale, raw scores were transformed and analyzed on a 0-100 scale. A high score indicated a high level of symptoms The scores were analyzed using repeated measurement model for longitudinal data, including terms for visit, treatment, treatment by time interaction, strata and baseline score. Overall mean and standard error were obtained.
dispersion Type
Standard Error
groups
  1. description
    Ceritinib administered continuously through oral dosing at a dosage of 750 mg once daily in fasted state
    id
    OG000
    title
    Ceritinib
  2. description
    Pemetrexed plus cisplatin or carboplatin (based on Investigator's choice) for 4 cycles (Induction) followed by pemetrexed as single agent (Maintenance)
    id
    OG001
    title
    Chemotherapy
param Type
LEAST_SQUARES_MEAN
population Description
The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization. Participants with a baseline assessment for at least one of the domain scores
reporting Status
POSTED
time Frame
Screening, treatment phase (Cycles 2, 3 then every 2nd cycle until Month 33; after Month 33, every 9 or 12 weeks, end of treatment); follow-up phase (Every 6 weeks until Month 33; after Month 33 every 9 or 12 weeks) up to approximately 120 months
title
Least Squares Mean Scores on the EORTC QLQ- LC13
type
SECONDARY
unit Of Measure
Score on a scale

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

Preserved source evidence · Not medical advice