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NCT04322539 · OUTCOME

Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life Scale 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

EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and global health status/QOL scale. EORTC QLQ-C30 contains 28 questions (4-point scale where 1=Not at all \[best\] to 4=Very Much \[worst\]) and 2 questions (7-point scale where 1=Very poor \[worst\] to 7= Excellent \[best\]). Raw scores are standardized and converted into scale scores ranging from 0 to 100. For global health status/QOL scale, higher scores represent better QOL. A negative change from baseline value indicates patient condition worsened. Change from baseline in the EORTC QLQ-C30 Global Health Status/Quality of Life Scale scores was performed by visit (i.e., cycle), using a restricted maximum likelihood (REML)-based mixed model repeated measures (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 timepoints.

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 Group330
Placebo + BSC Group149

Reported measurements

Cycle 2

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group330
Placebo + BSC Group149
Values in score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group-2.11.59Not reportedNot reportedNot reported
Placebo + BSC Group-3.71.95Not reportedNot reportedNot reported
Cycle 3

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group229
Placebo + BSC Group53
Values in score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group-4.51.69Not reportedNot reportedNot reported
Placebo + BSC Group-6.12.54Not reportedNot reportedNot reported
Cycle 4

Analysis denominator · Participants

GroupSource count
Fruquintinib + BSC Group182
Placebo + BSC Group29
Values in score on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Fruquintinib + BSC Group-4.21.76Not reportedNot reportedNot reported
Placebo + BSC Group-2.13.03Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.59
        value
        -2.1
      2. group Id
        OG001
        spread
        1.95
        value
        -3.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        330
      2. group Id
        OG001
        value
        149
      units
      Participants
    title
    Cycle 2
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.69
        value
        -4.5
      2. group Id
        OG001
        spread
        2.54
        value
        -6.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        229
      2. group Id
        OG001
        value
        53
      units
      Participants
    title
    Cycle 3
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.76
        value
        -4.2
      2. group Id
        OG001
        spread
        3.03
        value
        -2.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        182
      2. group Id
        OG001
        value
        29
      units
      Participants
    title
    Cycle 4
denoms
  1. counts
    1. group Id
      OG000
      value
      330
    2. group Id
      OG001
      value
      149
    units
    Participants
description
EORTC QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and global health status/QOL scale. EORTC QLQ-C30 contains 28 questions (4-point scale where 1=Not at all \[best\] to 4=Very Much \[worst\]) and 2 questions (7-point scale where 1=Very poor \[worst\] to 7= Excellent \[best\]). Raw scores are standardized and converted into scale scores ranging from 0 to 100. For global health status/QOL scale, higher scores represent better QOL. A negative change from baseline value indicates patient condition worsened. Change from baseline in the EORTC QLQ-C30 Global Health Status/Quality of Life Scale scores was performed by visit (i.e., cycle), using a restricted maximum likelihood (REML)-based mixed model repeated measures (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 timepoints.
reporting Status
POSTED
time Frame
Baseline, Cycle 2, 3 and 4 (Each cycle=28 days)
title
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life Scale 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