NCT04322539 · OUTCOME

Change From Baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Health Utility Index Scores

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

EQ-5D-5L consisted of 2 components: health state profile and optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problem, 2= slight problem, 3= moderate problem, 4= severe problem, and 5= extreme problem. The response levels collected from the EQ-5D-5L five dimensions as a health profile are converted into an EQ-5D-5L index (utility) scores to represent participants' utility value. The range of health utility index score is from -0.285 to 1, where higher value indicates perfect health and a negative value represents a state worse than dead. Change from baseline in EQ-5D-5L health utility index 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

Group	Source count
Fruquintinib + BSC Group	337
Placebo + BSC Group	151

Reported measurements

Cycle 2

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	337
Placebo + BSC Group	151

Values in score on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	0.0	0.01	Not reported	Not reported	Not reported
Placebo + BSC Group	0.0	0.02	Not reported	Not reported	Not reported

Cycle 3

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	232
Placebo + BSC Group	54

Values in score on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	0.0	0.01	Not reported	Not reported	Not reported
Placebo + BSC Group	0.0	0.02	Not reported	Not reported	Not reported

Cycle 4

Analysis denominator · Participants

Group	Source count
Fruquintinib + BSC Group	185
Placebo + BSC Group	30

Values in score on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Fruquintinib + BSC Group	-0.1	0.02	Not reported	Not reported	Not reported
Placebo + BSC Group	0.0	0.03	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.01
value
0.0
group Id
OG001
spread
0.02
value
0.0
denoms
counts
group Id
OG000
value
337
group Id
OG001
value
151
units
Participants
title
Cycle 2
categories
measurements
group Id
OG000
spread
0.01
value
0.0
group Id
OG001
spread
0.02
value
0.0
denoms
counts
group Id
OG000
value
232
group Id
OG001
value
54
units
Participants
title
Cycle 3
categories
measurements
group Id
OG000
spread
0.02
value
-0.1
group Id
OG001
spread
0.03
value
0.0
denoms
counts
group Id
OG000
value
185
group Id
OG001
value
30
units
Participants
title
Cycle 4

denoms

counts
group Id
OG000
value
337
group Id
OG001
value
151
units
Participants

description

dispersion Type

Standard Error

groups

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
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) Health Utility Index Scores

type

SECONDARY

unit Of Measure

score on a scale

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