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NCT04322539 · OUTCOME

Change From Baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score

A Study of Efficacy and Safety of Fruquintinib (HMPL-013) in Participants With Metastatic Colorectal Cancer · Source last updated 2025-04-04

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
Baseline, Cycle 2, 3 and 4 (Each cycle=28 days)

What was measured

The EQ-5D-5L is a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score. There were two components to the EQ-5D-5L: a five-item health state profile that assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score and a general VAS score for health status. EQ-5D VAS was used to record participant's rating for his/her current health-related quality of life state on a vertical VAS with scores ranging from 0 to 100, where 0 = worst imaginable health state and 100 = best imaginable health state. The higher the score the better the health status. A negative change from baseline value represents patient condition worsened. Change from baseline in the EQ-5D-5L VAS scores was performed by visit (i.e. cycle), using a REML-based MMRM approach.

Analysis population: ITT population included all randomized participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" signifies those participants who were evaluable at the specified categories.

Groups in this outcome

Fruquintinib + BSC Group

Participants received 5 mg of fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).

Placebo + BSC Group

Participants received placebo matched to fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).

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

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group388
Placebo + BSC Group230

Reported measurements

Cycle 2

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group337
Placebo + BSC Group151
Values in score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group-0.31.38Not reportedNot reportedNot reported
Placebo + BSC Group-0.91.69Not reportedNot reportedNot reported
Cycle 3

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group232
Placebo + BSC Group54
Values in score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group-1.11.48Not reportedNot reportedNot reported
Placebo + BSC Group-2.52.22Not reportedNot reportedNot reported
Cycle 4

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group185
Placebo + BSC Group30
Values in score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group-4.01.59Not reportedNot reportedNot reported
Placebo + BSC Group-2.12.79Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.38
        value
        -0.3
      2. group Id
        OG001
        spread
        1.69
        value
        -0.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        337
      2. group Id
        OG001
        value
        151
      units
      Participants
    title
    Cycle 2
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.48
        value
        -1.1
      2. group Id
        OG001
        spread
        2.22
        value
        -2.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        232
      2. group Id
        OG001
        value
        54
      units
      Participants
    title
    Cycle 3
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.59
        value
        -4.0
      2. group Id
        OG001
        spread
        2.79
        value
        -2.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        185
      2. group Id
        OG001
        value
        30
      units
      Participants
    title
    Cycle 4
denoms
  1. counts
    1. group Id
      OG000
      value
      388
    2. group Id
      OG001
      value
      230
    units
    Participants
description
The EQ-5D-5L is a self-reported health status questionnaire that consisted of six questions used to calculate a health utility score. There were two components to the EQ-5D-5L: a five-item health state profile that assessed mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score and a general VAS score for health status. EQ-5D VAS was used to record participant's rating for his/her current health-related quality of life state on a vertical VAS with scores ranging from 0 to 100, where 0 = worst imaginable health state and 100 = best imaginable health state. The higher the score the better the health status. A negative change from baseline value represents patient condition worsened. Change from baseline in the EQ-5D-5L VAS scores was performed by visit (i.e. cycle), using a REML-based MMRM approach.
dispersion Type
Standard Error
groups
  1. description
    Participants received 5 mg of fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).
    id
    OG000
    title
    Fruquintinib + BSC Group
  2. description
    Participants received placebo matched to fruquintinib oral capsule in combination with BSC once daily for 3 weeks of continuous dosing followed by a 1-week break during a treatment cycle (Each cycle length was 28 days).
    id
    OG001
    title
    Placebo + BSC Group
param Type
LEAST_SQUARES_MEAN
population Description
ITT population included all randomized participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" signifies those participants who were evaluable at the specified categories.
reporting Status
POSTED
time Frame
Baseline, Cycle 2, 3 and 4 (Each cycle=28 days)
title
Change From Baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score
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