Change From Baseline In QoL Total Score For Remaining Domain Scores As Assessed By The EORTC-QLQ-C30
A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer · Source last updated 2022-01-18
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, Week 49 Day 1 (Day 337)
What was measured
The EORTC QLQ-C30 core measurement was used to capture distal outcomes, including physical, social functioning, and overall health-related quality of life. The questionnaire incorporates 30 questions comprising nine multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 3 symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality of life scale. All raw domain scores are linearly transformed to a 0-100 scale. All domains except for the global health and quality are presented. An increase in activity or functioning scores indicates improvement (higher/healthier level of functioning) and a decrease in symptom scores indicates improvement (lower level of symptoms/problems).
Analysis population: All randomized participants who received at least 1 dose of study drug and had analyzable data at the specified timepoint.
Groups in this outcome
Relugolix
Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
Leuprolide Acetate
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
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
Relugolix
543
Leuprolide Acetate
257
Reported measurements
Physical functioning
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Relugolix
-4.6
13.09
Not reported
Not reported
Not reported
Leuprolide Acetate
-4.4
12.29
Not reported
Not reported
Not reported
Role functioning
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Relugolix
-6.2
19.92
Not reported
Not reported
Not reported
Leuprolide Acetate
-5.6
17.84
Not reported
Not reported
Not reported
Emotional functioning
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Relugolix
0.5
16.12
Not reported
Not reported
Not reported
Leuprolide Acetate
-0.5
13.23
Not reported
Not reported
Not reported
Cognitive functioning
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Relugolix
-3.7
16.77
Not reported
Not reported
Not reported
Leuprolide Acetate
-3.8
16.37
Not reported
Not reported
Not reported
Social functioning
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Relugolix
-2.7
18.31
Not reported
Not reported
Not reported
Leuprolide Acetate
-4.0
18.18
Not reported
Not reported
Not reported
Fatigue
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Relugolix
6.1
19.46
Not reported
Not reported
Not reported
Leuprolide Acetate
7.0
18.40
Not reported
Not reported
Not reported
Nausea and vomiting
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Relugolix
0.2
7.12
Not reported
Not reported
Not reported
Leuprolide Acetate
0.8
6.02
Not reported
Not reported
Not reported
Pain
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Relugolix
1.7
20.19
Not reported
Not reported
Not reported
Leuprolide Acetate
4.0
21.96
Not reported
Not reported
Not reported
Dyspnoea
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Relugolix
5.3
19.16
Not reported
Not reported
Not reported
Leuprolide Acetate
7.9
20.25
Not reported
Not reported
Not reported
Insomnia
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Relugolix
4.8
25.88
Not reported
Not reported
Not reported
Leuprolide Acetate
4.8
21.82
Not reported
Not reported
Not reported
Appetite loss
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Relugolix
-0.6
17.82
Not reported
Not reported
Not reported
Leuprolide Acetate
-0.6
14.86
Not reported
Not reported
Not reported
Constipation
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Relugolix
1.4
23.26
Not reported
Not reported
Not reported
Leuprolide Acetate
3.5
18.88
Not reported
Not reported
Not reported
Diarrhoea
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Relugolix
2.0
16.70
Not reported
Not reported
Not reported
Leuprolide Acetate
1.4
19.60
Not reported
Not reported
Not reported
Financial difficulties
Values in score on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Relugolix
0.2
18.28
Not reported
Not reported
Not reported
Leuprolide Acetate
0.1
19.21
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
13.09
value
-4.6
group Id
OG001
spread
12.29
value
-4.4
title
Physical functioning
categories
measurements
group Id
OG000
spread
19.92
value
-6.2
group Id
OG001
spread
17.84
value
-5.6
title
Role functioning
categories
measurements
group Id
OG000
spread
16.12
value
0.5
group Id
OG001
spread
13.23
value
-0.5
title
Emotional functioning
categories
measurements
group Id
OG000
spread
16.77
value
-3.7
group Id
OG001
spread
16.37
value
-3.8
title
Cognitive functioning
categories
measurements
group Id
OG000
spread
18.31
value
-2.7
group Id
OG001
spread
18.18
value
-4.0
title
Social functioning
categories
measurements
group Id
OG000
spread
19.46
value
6.1
group Id
OG001
spread
18.40
value
7.0
title
Fatigue
categories
measurements
group Id
OG000
spread
7.12
value
0.2
group Id
OG001
spread
6.02
value
0.8
title
Nausea and vomiting
categories
measurements
group Id
OG000
spread
20.19
value
1.7
group Id
OG001
spread
21.96
value
4.0
title
Pain
categories
measurements
group Id
OG000
spread
19.16
value
5.3
group Id
OG001
spread
20.25
value
7.9
title
Dyspnoea
categories
measurements
group Id
OG000
spread
25.88
value
4.8
group Id
OG001
spread
21.82
value
4.8
title
Insomnia
categories
measurements
group Id
OG000
spread
17.82
value
-0.6
group Id
OG001
spread
14.86
value
-0.6
title
Appetite loss
categories
measurements
group Id
OG000
spread
23.26
value
1.4
group Id
OG001
spread
18.88
value
3.5
title
Constipation
denoms
counts
group Id
OG000
value
543
group Id
OG001
value
257
units
Participants
description
The EORTC QLQ-C30 core measurement was used to capture distal outcomes, including physical, social functioning, and overall health-related quality of life. The questionnaire incorporates 30 questions comprising nine multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 3 symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality of life scale. All raw domain scores are linearly transformed to a 0-100 scale. All domains except for the global health and quality are presented. An increase in activity or functioning scores indicates improvement (higher/healthier level of functioning) and a decrease in symptom scores indicates improvement (lower level of symptoms/problems).
dispersion Type
Standard Deviation
groups
description
Relugolix 120-mg tablet administered orally once daily for 48 weeks following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1.
id
OG000
title
Relugolix
description
Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan and Taiwan), every 3 months by subcutaneous injection.
id
OG001
title
Leuprolide Acetate
param Type
MEAN
population Description
All randomized participants who received at least 1 dose of study drug and had analyzable data at the specified timepoint.
reporting Status
POSTED
time Frame
Baseline, Week 49 Day 1 (Day 337)
title
Change From Baseline In QoL Total Score For Remaining Domain Scores As Assessed By The EORTC-QLQ-C30
Triangle