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NCT02052778 · OUTCOME

Phase 2: Change From Baseline in EQ-5D-3L Visual Analogue Scale (VAS) at Specified Visits

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 a 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

EQ-5D-3L was a self-administered standardized questionnaire to assess health outcome. It comprised 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. A vertical VAS allows the participants to indicate their health state that day, and ranged from 0 (worst imaginable) to 100 (best imaginable), with higher scores indicating better health state.

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 288
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 271.7220.307Not reportedNot reportedNot reported
Change at Cycle 2

Analysis denominator · Participants

GroupSource count
Phase 277
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2-0.7319.409Not reportedNot reportedNot reported
Change at Cycle 4

Analysis denominator · Participants

GroupSource count
Phase 274
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2-1.0423.984Not reportedNot reportedNot reported
Change at Cycle 7

Analysis denominator · Participants

GroupSource count
Phase 262
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2-1.8229.984Not reportedNot reportedNot reported
Change at Cycle 10

Analysis denominator · Participants

GroupSource count
Phase 254
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 20.4030.428Not reportedNot reportedNot reported
Change at Cycle 13

Analysis denominator · Participants

GroupSource count
Phase 245
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 24.7626.585Not reportedNot reportedNot reported
Change at Cycle 16

Analysis denominator · Participants

GroupSource count
Phase 233
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2-1.7134.417Not reportedNot reportedNot reported
Change at Cycle 19

Analysis denominator · Participants

GroupSource count
Phase 227
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 21.7625.155Not reportedNot reportedNot reported
Change at Cycle 22

Analysis denominator · Participants

GroupSource count
Phase 220
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 21.8531.707Not reportedNot reportedNot reported
Change at Cycle 25

Analysis denominator · Participants

GroupSource count
Phase 211
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2-0.8245.828Not reportedNot reportedNot reported
Change at Cycle 28

Analysis denominator · Participants

GroupSource count
Phase 28
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2-1.8540.912Not reportedNot reportedNot reported
Change at Cycle 31

Analysis denominator · Participants

GroupSource count
Phase 23
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 218.1717.280Not reportedNot reportedNot reported
Change at Cycle 34

Analysis denominator · Participants

GroupSource count
Phase 23
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 219.0019.313Not reportedNot reportedNot reported
Change at Cycle 37

Analysis denominator · Participants

GroupSource count
Phase 23
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 215.1721.624Not reportedNot reportedNot reported
Change at Cycle 40

Analysis denominator · Participants

GroupSource count
Phase 21
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 215.00Not reportedNot reportedNot reportedNot reported
End of Treatment

Analysis denominator · Participants

GroupSource count
Phase 241
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2-8.8926.272Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.307
        value
        71.72
    denoms
    1. counts
      1. group Id
        OG000
        value
        88
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.409
        value
        -0.73
    denoms
    1. counts
      1. group Id
        OG000
        value
        77
      units
      Participants
    title
    Change at Cycle 2
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.984
        value
        -1.04
    denoms
    1. counts
      1. group Id
        OG000
        value
        74
      units
      Participants
    title
    Change at Cycle 4
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        29.984
        value
        -1.82
    denoms
    1. counts
      1. group Id
        OG000
        value
        62
      units
      Participants
    title
    Change at Cycle 7
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.428
        value
        0.40
    denoms
    1. counts
      1. group Id
        OG000
        value
        54
      units
      Participants
    title
    Change at Cycle 10
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        26.585
        value
        4.76
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      units
      Participants
    title
    Change at Cycle 13
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        34.417
        value
        -1.71
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      units
      Participants
    title
    Change at Cycle 16
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.155
        value
        1.76
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      units
      Participants
    title
    Change at Cycle 19
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        31.707
        value
        1.85
    denoms
    1. counts
      1. group Id
        OG000
        value
        20
      units
      Participants
    title
    Change at Cycle 22
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        45.828
        value
        -0.82
    denoms
    1. counts
      1. group Id
        OG000
        value
        11
      units
      Participants
    title
    Change at Cycle 25
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        40.912
        value
        -1.85
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      units
      Participants
    title
    Change at Cycle 28
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.280
        value
        18.17
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      units
      Participants
    title
    Change at Cycle 31
denoms
  1. counts
    1. group Id
      OG000
      value
      92
    units
    Participants
description
EQ-5D-3L was a self-administered standardized questionnaire to assess health outcome. It comprised 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. A vertical VAS allows the participants to indicate their health state that day, and ranged from 0 (worst imaginable) to 100 (best imaginable), with higher scores indicating better health state.
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 EQ-5D-3L Visual Analogue Scale (VAS) at Specified Visits
type
SECONDARY
unit Of Measure
score on a scale

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

Preserved source evidence · Not medical advice