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NCT04737187 · OUTCOME

Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints

Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients · Source last updated 2024-09-24

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 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11, Cycle 12, Cycle 13 and Cycle 14

What was measured

The EQ-5D-5L is a standardized measure of health status that provides a general assessment of health utility and consist of 2 sections; descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and a VAS. The VAS records the respondent's self-rated health on a 20 centimeter (cm) vertical VAS; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). This information can be used as a quantitative measure of health as judged by the individual respondents.

Analysis population: Analysis was performed on FAS population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category.

Groups in this outcome

Trifluridine/Tipiracil + Bevacizumab

Participants were administered 35 mg/m²/dose FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest; with bevacizumab 5 mg/kg, IV infusion administered every 2 weeks (Day 1 and Day 15). This treatment cycle was repeated every 4 weeks.

Trifluridine/Tipiracil

Participants were administered 35 mg/m²/dose of FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest. This treatment cycle was repeated every 4 weeks.

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

Analysis denominator · Participants

GroupSource count
Trifluridine/Tipiracil + Bevacizumab201
Trifluridine/Tipiracil207

Reported measurements

Cycle 1

Analysis denominator · Participants

GroupSource count
Trifluridine/Tipiracil + Bevacizumab201
Trifluridine/Tipiracil207
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trifluridine/Tipiracil + Bevacizumab2.09516.256Not reportedNot reportedNot reported
Trifluridine/Tipiracil0.05815.749Not reportedNot reportedNot reported
Cycle 2

Analysis denominator · Participants

GroupSource count
Trifluridine/Tipiracil + Bevacizumab196
Trifluridine/Tipiracil182
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trifluridine/Tipiracil + Bevacizumab0.85215.696Not reportedNot reportedNot reported
Trifluridine/Tipiracil-4.24218.302Not reportedNot reportedNot reported
Cycle 3

Analysis denominator · Participants

GroupSource count
Trifluridine/Tipiracil + Bevacizumab165
Trifluridine/Tipiracil101
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trifluridine/Tipiracil + Bevacizumab0.29717.618Not reportedNot reportedNot reported
Trifluridine/Tipiracil-1.60415.729Not reportedNot reportedNot reported
Cycle 4

Analysis denominator · Participants

GroupSource count
Trifluridine/Tipiracil + Bevacizumab146
Trifluridine/Tipiracil81
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trifluridine/Tipiracil + Bevacizumab-0.52118.177Not reportedNot reportedNot reported
Trifluridine/Tipiracil-3.24717.769Not reportedNot reportedNot reported
Cycle 5

Analysis denominator · Participants

GroupSource count
Trifluridine/Tipiracil + Bevacizumab114
Trifluridine/Tipiracil48
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trifluridine/Tipiracil + Bevacizumab1.90416.908Not reportedNot reportedNot reported
Trifluridine/Tipiracil-1.27116.738Not reportedNot reportedNot reported
Cycle 6

Analysis denominator · Participants

GroupSource count
Trifluridine/Tipiracil + Bevacizumab98
Trifluridine/Tipiracil39
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trifluridine/Tipiracil + Bevacizumab2.78616.162Not reportedNot reportedNot reported
Trifluridine/Tipiracil-3.51318.602Not reportedNot reportedNot reported
Cycle 7

Analysis denominator · Participants

GroupSource count
Trifluridine/Tipiracil + Bevacizumab74
Trifluridine/Tipiracil24
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trifluridine/Tipiracil + Bevacizumab1.50016.730Not reportedNot reportedNot reported
Trifluridine/Tipiracil-2.70816.573Not reportedNot reportedNot reported
Cycle 8

Analysis denominator · Participants

GroupSource count
Trifluridine/Tipiracil + Bevacizumab68
Trifluridine/Tipiracil17
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trifluridine/Tipiracil + Bevacizumab0.22115.635Not reportedNot reportedNot reported
Trifluridine/Tipiracil-0.35316.328Not reportedNot reportedNot reported
Cycle 9

Analysis denominator · Participants

GroupSource count
Trifluridine/Tipiracil + Bevacizumab51
Trifluridine/Tipiracil10
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trifluridine/Tipiracil + Bevacizumab-1.74514.085Not reportedNot reportedNot reported
Trifluridine/Tipiracil3.40011.928Not reportedNot reportedNot reported
Cycle 10

Analysis denominator · Participants

GroupSource count
Trifluridine/Tipiracil + Bevacizumab43
Trifluridine/Tipiracil8
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trifluridine/Tipiracil + Bevacizumab-1.95313.991Not reportedNot reportedNot reported
Trifluridine/Tipiracil-4.50025.785Not reportedNot reportedNot reported
Cycle 11

Analysis denominator · Participants

GroupSource count
Trifluridine/Tipiracil + Bevacizumab33
Trifluridine/Tipiracil6
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trifluridine/Tipiracil + Bevacizumab-1.21216.328Not reportedNot reportedNot reported
Trifluridine/Tipiracil2.83316.388Not reportedNot reportedNot reported
Cycle 12

Analysis denominator · Participants

GroupSource count
Trifluridine/Tipiracil + Bevacizumab26
Trifluridine/Tipiracil4
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trifluridine/Tipiracil + Bevacizumab2.38513.674Not reportedNot reportedNot reported
Trifluridine/Tipiracil8.00015.188Not reportedNot reportedNot reported
Cycle 13

Analysis denominator · Participants

GroupSource count
Trifluridine/Tipiracil + Bevacizumab18
Trifluridine/Tipiracil1
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trifluridine/Tipiracil + Bevacizumab-2.05615.757Not reportedNot reportedNot reported
Trifluridine/Tipiracil13.000Not reportedNot reportedNot reportedNot reported
Cycle 14

Analysis denominator · Participants

GroupSource count
Trifluridine/Tipiracil + Bevacizumab11
Trifluridine/Tipiracil1
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trifluridine/Tipiracil + Bevacizumab0.54515.952Not reportedNot reportedNot reported
Trifluridine/Tipiracil13.000Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.256
        value
        2.095
      2. group Id
        OG001
        spread
        15.749
        value
        0.058
    denoms
    1. counts
      1. group Id
        OG000
        value
        201
      2. group Id
        OG001
        value
        207
      units
      Participants
    title
    Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.696
        value
        0.852
      2. group Id
        OG001
        spread
        18.302
        value
        -4.242
    denoms
    1. counts
      1. group Id
        OG000
        value
        196
      2. group Id
        OG001
        value
        182
      units
      Participants
    title
    Cycle 2
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.618
        value
        0.297
      2. group Id
        OG001
        spread
        15.729
        value
        -1.604
    denoms
    1. counts
      1. group Id
        OG000
        value
        165
      2. group Id
        OG001
        value
        101
      units
      Participants
    title
    Cycle 3
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        18.177
        value
        -0.521
      2. group Id
        OG001
        spread
        17.769
        value
        -3.247
    denoms
    1. counts
      1. group Id
        OG000
        value
        146
      2. group Id
        OG001
        value
        81
      units
      Participants
    title
    Cycle 4
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.908
        value
        1.904
      2. group Id
        OG001
        spread
        16.738
        value
        -1.271
    denoms
    1. counts
      1. group Id
        OG000
        value
        114
      2. group Id
        OG001
        value
        48
      units
      Participants
    title
    Cycle 5
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.162
        value
        2.786
      2. group Id
        OG001
        spread
        18.602
        value
        -3.513
    denoms
    1. counts
      1. group Id
        OG000
        value
        98
      2. group Id
        OG001
        value
        39
      units
      Participants
    title
    Cycle 6
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.730
        value
        1.500
      2. group Id
        OG001
        spread
        16.573
        value
        -2.708
    denoms
    1. counts
      1. group Id
        OG000
        value
        74
      2. group Id
        OG001
        value
        24
      units
      Participants
    title
    Cycle 7
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.635
        value
        0.221
      2. group Id
        OG001
        spread
        16.328
        value
        -0.353
    denoms
    1. counts
      1. group Id
        OG000
        value
        68
      2. group Id
        OG001
        value
        17
      units
      Participants
    title
    Cycle 8
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        14.085
        value
        -1.745
      2. group Id
        OG001
        spread
        11.928
        value
        3.400
    denoms
    1. counts
      1. group Id
        OG000
        value
        51
      2. group Id
        OG001
        value
        10
      units
      Participants
    title
    Cycle 9
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.991
        value
        -1.953
      2. group Id
        OG001
        spread
        25.785
        value
        -4.500
    denoms
    1. counts
      1. group Id
        OG000
        value
        43
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    Cycle 10
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.328
        value
        -1.212
      2. group Id
        OG001
        spread
        16.388
        value
        2.833
    denoms
    1. counts
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Cycle 11
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.674
        value
        2.385
      2. group Id
        OG001
        spread
        15.188
        value
        8.000
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    Cycle 12
denoms
  1. counts
    1. group Id
      OG000
      value
      201
    2. group Id
      OG001
      value
      207
    units
    Participants
description
The EQ-5D-5L is a standardized measure of health status that provides a general assessment of health utility and consist of 2 sections; descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and a VAS. The VAS records the respondent's self-rated health on a 20 centimeter (cm) vertical VAS; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). This information can be used as a quantitative measure of health as judged by the individual respondents.
dispersion Type
Standard Deviation
groups
  1. description
    Participants were administered 35 mg/m²/dose FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest; with bevacizumab 5 mg/kg, IV infusion administered every 2 weeks (Day 1 and Day 15). This treatment cycle was repeated every 4 weeks.
    id
    OG000
    title
    Trifluridine/Tipiracil + Bevacizumab
  2. description
    Participants were administered 35 mg/m²/dose of FTD/TPI orally BID, within 1 hour after completion of morning and evening meals, 5 days on (Day 1 to 5 and Day 8 to 12) with 2 days off (Day 6 to 7 and Day 13 to 14), over 2 weeks, followed by a 14-day rest. This treatment cycle was repeated every 4 weeks.
    id
    OG001
    title
    Trifluridine/Tipiracil
param Type
MEAN
population Description
Analysis was performed on FAS population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' = participants with available data for each specified category.
reporting Status
POSTED
time Frame
Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6, Cycle 7, Cycle 8, Cycle 9, Cycle 10, Cycle 11, Cycle 12, Cycle 13 and Cycle 14
title
Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Score: Visual Analogic Scale (VAS) at Specified Timepoints
type
SECONDARY
unit Of Measure
score on a scale

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

Preserved source evidence · Independent clinical review pending · Not medical advice