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NCT04737187 · OUTCOME

Change From Baseline in European Quality of Life Group Questionnaire With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Health State Utility Index Value 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 in 2 sections a descriptive system comprising 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and Visual Analog Scale (VAS). Each dimension has a 5-level response: no problems, slight problems, moderate problems, severe problems, and extreme problems. Response options are measured with a 5-point Likert scale. The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state and lower score indicate worse health state.

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 + Bevacizumab0.0040.125Not reportedNot reportedNot reported
Trifluridine/Tipiracil0.0010.163Not 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 + Bevacizumab-0.0030.114Not reportedNot reportedNot reported
Trifluridine/Tipiracil-0.0300.153Not 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 + Bevacizumab-0.0140.107Not reportedNot reportedNot reported
Trifluridine/Tipiracil0.0020.188Not 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-0.0160.111Not reportedNot reportedNot reported
Trifluridine/Tipiracil-0.0140.209Not 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 + Bevacizumab-0.0030.101Not reportedNot reportedNot reported
Trifluridine/Tipiracil0.0040.120Not 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 + Bevacizumab-0.0100.112Not reportedNot reportedNot reported
Trifluridine/Tipiracil-0.0030.094Not 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 + Bevacizumab-0.0070.078Not reportedNot reportedNot reported
Trifluridine/Tipiracil0.0020.105Not 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 + Bevacizumab-0.0160.097Not reportedNot reportedNot reported
Trifluridine/Tipiracil-0.0280.109Not 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-0.0240.149Not reportedNot reportedNot reported
Trifluridine/Tipiracil0.0320.085Not 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-0.0030.094Not reportedNot reportedNot reported
Trifluridine/Tipiracil0.0180.106Not 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-0.0080.105Not reportedNot reportedNot reported
Trifluridine/Tipiracil0.0080.104Not 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 + Bevacizumab-0.0250.113Not reportedNot reportedNot reported
Trifluridine/Tipiracil0.0300.039Not 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-0.0370.112Not reportedNot reportedNot reported
Trifluridine/Tipiracil0.015Not 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 + Bevacizumab-0.0340.062Not reportedNot reportedNot reported
Trifluridine/Tipiracil0.016Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.125
        value
        0.004
      2. group Id
        OG001
        spread
        0.163
        value
        0.001
    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
        0.114
        value
        -0.003
      2. group Id
        OG001
        spread
        0.153
        value
        -0.030
    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
        0.107
        value
        -0.014
      2. group Id
        OG001
        spread
        0.188
        value
        0.002
    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
        0.111
        value
        -0.016
      2. group Id
        OG001
        spread
        0.209
        value
        -0.014
    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
        0.101
        value
        -0.003
      2. group Id
        OG001
        spread
        0.120
        value
        0.004
    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
        0.112
        value
        -0.010
      2. group Id
        OG001
        spread
        0.094
        value
        -0.003
    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
        0.078
        value
        -0.007
      2. group Id
        OG001
        spread
        0.105
        value
        0.002
    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
        0.097
        value
        -0.016
      2. group Id
        OG001
        spread
        0.109
        value
        -0.028
    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
        0.149
        value
        -0.024
      2. group Id
        OG001
        spread
        0.085
        value
        0.032
    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
        0.094
        value
        -0.003
      2. group Id
        OG001
        spread
        0.106
        value
        0.018
    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
        0.105
        value
        -0.008
      2. group Id
        OG001
        spread
        0.104
        value
        0.008
    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
        0.113
        value
        -0.025
      2. group Id
        OG001
        spread
        0.039
        value
        0.030
    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 in 2 sections a descriptive system comprising 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and Visual Analog Scale (VAS). Each dimension has a 5-level response: no problems, slight problems, moderate problems, severe problems, and extreme problems. Response options are measured with a 5-point Likert scale. The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state and lower score indicate worse health state.
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 Group Questionnaire With 5 Dimensions and 5 Levels Per Dimension (EQ-5D-5L): Health State Utility Index Value 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