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NCT02052778 · OUTCOME

Phase 2:Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status Score at Specified Timepoints

A Study of TAS-120 in Patients With Advanced Solid Tumors · Source last updated 2025-03-27

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

Measure
MEAN
Unit
score on scale
Interval / dispersion
Standard Deviation
Time frame
Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40 and end of treatment (i.e., Cycle 43 [30 months])

What was measured

EORTC QLQ-C30 is a cancer-specific instrument that contains 30 questions for evaluation of new chemotherapy \& assessment of participant reported outcome. EORTC QLQ-C30 included global health status/quality of life (GHS/QOL), functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 are 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale \& are 7-point scale (1/Very Poor to 7/Excellent). GHS total score is calculated as (\[{Q29+Q30}/2\]-1)/6\*100. Answers are converted into grading scale, with values between 0 (worse outcome) to100 (best outcome). High score represents a favorable outcome with best quality of life for participant.

Analysis population: Analysis was performed on PRO population. Here, 'number analyzed' = number of participants with available data for each specified category.

Groups in this outcome

Phase 2

Participants with iCCA with tumors harboring FGFR2 gene rearrangements received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.

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

Analysis denominator · Participants

GroupSource count
Phase 292

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
Phase 291
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 270.119.41Not reportedNot reportedNot reported
Change at Cycle 2

Analysis denominator · Participants

GroupSource count
Phase 283
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2-1.022.02Not reportedNot reportedNot reported
Change at Cycle 4

Analysis denominator · Participants

GroupSource count
Phase 279
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 20.420.62Not reportedNot reportedNot reported
Change at Cycle 7

Analysis denominator · Participants

GroupSource count
Phase 265
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2-0.521.64Not reportedNot reportedNot reported
Change at Cycle 10

Analysis denominator · Participants

GroupSource count
Phase 258
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 21.922.84Not reportedNot reportedNot reported
Change at Cycle 13

Analysis denominator · Participants

GroupSource count
Phase 248
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 20.921.49Not reportedNot reportedNot reported
Change at Cycle 16

Analysis denominator · Participants

GroupSource count
Phase 227
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 22.518.61Not reportedNot reportedNot reported
Change at Cycle 19

Analysis denominator · Participants

GroupSource count
Phase 215
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2-1.717.31Not reportedNot reportedNot reported
Change at Cycle 22

Analysis denominator · Participants

GroupSource count
Phase 211
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2-8.322.05Not reportedNot reportedNot reported
Change at Cycle 25

Analysis denominator · Participants

GroupSource count
Phase 27
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2-4.821.44Not reportedNot reportedNot reported
Change at Cycle 28

Analysis denominator · Participants

GroupSource count
Phase 24
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2-6.312.50Not reportedNot reportedNot reported
Change at Cycle 31

Analysis denominator · Participants

GroupSource count
Phase 21
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 241.7Not reportedNot reportedNot reportedNot reported
Change at Cycle 34

Analysis denominator · Participants

GroupSource count
Phase 21
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 241.7Not reportedNot reportedNot reportedNot reported
End of Treatment

Analysis denominator · Participants

GroupSource count
Phase 230
Values in score on scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2-7.523.30Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.41
        value
        70.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        91
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.02
        value
        -1.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        83
      units
      Participants
    title
    Change at Cycle 2
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.62
        value
        0.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        79
      units
      Participants
    title
    Change at Cycle 4
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.64
        value
        -0.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        65
      units
      Participants
    title
    Change at Cycle 7
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.84
        value
        1.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        58
      units
      Participants
    title
    Change at Cycle 10
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.49
        value
        0.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        48
      units
      Participants
    title
    Change at Cycle 13
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.61
        value
        2.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      units
      Participants
    title
    Change at Cycle 16
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.31
        value
        -1.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        15
      units
      Participants
    title
    Change at Cycle 19
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.05
        value
        -8.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      units
      Participants
    title
    Change at Cycle 22
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.44
        value
        -4.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      units
      Participants
    title
    Change at Cycle 25
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.50
        value
        -6.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Change at Cycle 28
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        41.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Change at Cycle 31
denoms
  1. counts
    1. group Id
      OG000
      value
      92
    units
    Participants
description
EORTC QLQ-C30 is a cancer-specific instrument that contains 30 questions for evaluation of new chemotherapy \& assessment of participant reported outcome. EORTC QLQ-C30 included global health status/quality of life (GHS/QOL), functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, nausea/vomiting), and 6 single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, financial difficulties). Most questions from QLQ-C30 are 4-point scale (1/Not at All to 4/Very Much), except Items 29-30, which comprise GHS scale \& are 7-point scale (1/Very Poor to 7/Excellent). GHS total score is calculated as (\[{Q29+Q30}/2\]-1)/6\*100. Answers are converted into grading scale, with values between 0 (worse outcome) to100 (best outcome). High score represents a favorable outcome with best quality of life for participant.
dispersion Type
Standard Deviation
groups
  1. description
    Participants with iCCA with tumors harboring FGFR2 gene rearrangements received TAS-120 20 mg tablets orally QD in each of 21-day treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent or death.
    id
    OG000
    title
    Phase 2
param Type
MEAN
population Description
Analysis was performed on PRO population. Here, 'number analyzed' = number of participants with available data for each specified category.
reporting Status
POSTED
time Frame
Baseline, Cycle 2, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40 and end of treatment (i.e., Cycle 43 [30 months])
title
Phase 2:Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status Score at Specified Timepoints
type
SECONDARY
unit Of Measure
score on scale

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

Preserved source evidence · Not medical advice