Change From Baseline in Quality of Life European Organization for Research and Treatment for Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30 Score): Global Health Status
Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer · Source last updated 2024-09-03
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
MEAN
Unit
units on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline, Day 1 Cycle 2 up to end of treatment (EOT) (within 30 days of last study treatment) and 30-Day safety follow-up visit (maximum duration: up to approximately 46 months)
What was measured
EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical,role,emotional,cognitive,social), 3 symptom scales (fatigue,nausea/vomiting,pain) and other single items. For each item,high score represented high level of symptomatology/problem. Last 2 questions represented participant's assessment of overall health and QoL, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 and 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favorable outcome with a best QoL for participant.
Analysis population: Analysis was performed on the ITT population that included all randomized participants, regardless of whether or not study treatment was administered. Here, 'number analyzed' = participants with available data for each specified category.
Groups in this outcome
TAS-102+BSC
Participants received 35 mg/m\^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
Placebo+BSC
Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
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
TAS-102+BSC
337
Placebo+BSC
170
Reported measurements
Cycle 1
Analysis denominator · Participants
Group
Source count
TAS-102+BSC
279
Placebo+BSC
127
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
TAS-102+BSC
-2.7
17.56
Not reported
Not reported
Not reported
Placebo+BSC
-5.9
22.20
Not reported
Not reported
Not reported
Cycle 2
Analysis denominator · Participants
Group
Source count
TAS-102+BSC
187
Placebo+BSC
58
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
TAS-102+BSC
-5.9
20.51
Not reported
Not reported
Not reported
Placebo+BSC
-7.3
25.80
Not reported
Not reported
Not reported
Cycle 3
Analysis denominator · Participants
Group
Source count
TAS-102+BSC
121
Placebo+BSC
23
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
TAS-102+BSC
-4.1
18.26
Not reported
Not reported
Not reported
Placebo+BSC
-1.4
22.00
Not reported
Not reported
Not reported
Cycle 4
Analysis denominator · Participants
Group
Source count
TAS-102+BSC
79
Placebo+BSC
15
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
TAS-102+BSC
-3.6
17.54
Not reported
Not reported
Not reported
Placebo+BSC
-1.7
22.32
Not reported
Not reported
Not reported
Cycle 5
Analysis denominator · Participants
Group
Source count
TAS-102+BSC
55
Placebo+BSC
9
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
TAS-102+BSC
-5.9
18.05
Not reported
Not reported
Not reported
Placebo+BSC
11.1
18.16
Not reported
Not reported
Not reported
Cycle 6
Analysis denominator · Participants
Group
Source count
TAS-102+BSC
36
Placebo+BSC
8
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
TAS-102+BSC
-8.8
23.05
Not reported
Not reported
Not reported
Placebo+BSC
15.6
21.10
Not reported
Not reported
Not reported
Cycle 7
Analysis denominator · Participants
Group
Source count
TAS-102+BSC
28
Placebo+BSC
5
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
TAS-102+BSC
-9.5
21.96
Not reported
Not reported
Not reported
Placebo+BSC
20.0
4.56
Not reported
Not reported
Not reported
Cycle 8
Analysis denominator · Participants
Group
Source count
TAS-102+BSC
23
Placebo+BSC
5
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
TAS-102+BSC
-4.3
23.82
Not reported
Not reported
Not reported
Placebo+BSC
16.7
11.79
Not reported
Not reported
Not reported
Cycle 9
Analysis denominator · Participants
Group
Source count
TAS-102+BSC
14
Placebo+BSC
3
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
TAS-102+BSC
2.4
17.12
Not reported
Not reported
Not reported
Placebo+BSC
16.7
16.67
Not reported
Not reported
Not reported
Cycle 10
Analysis denominator · Participants
Group
Source count
TAS-102+BSC
11
Placebo+BSC
2
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
TAS-102+BSC
-14.4
25.57
Not reported
Not reported
Not reported
Placebo+BSC
25.0
11.79
Not reported
Not reported
Not reported
Cycle 11
Analysis denominator · Participants
Group
Source count
TAS-102+BSC
5
Placebo+BSC
2
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
TAS-102+BSC
-16.7
37.27
Not reported
Not reported
Not reported
Placebo+BSC
25.0
11.79
Not reported
Not reported
Not reported
Cycle 12
Analysis denominator · Participants
Group
Source count
TAS-102+BSC
2
Placebo+BSC
1
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
TAS-102+BSC
-8.3
11.79
Not reported
Not reported
Not reported
Placebo+BSC
33.3
Not reported
Not reported
Not reported
Not reported
Cycle 13
Analysis denominator · Participants
Group
Source count
TAS-102+BSC
1
Placebo+BSC
1
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
TAS-102+BSC
0.0
Not reported
Not reported
Not reported
Not reported
Placebo+BSC
33.3
Not reported
Not reported
Not reported
Not reported
Cycle 14
Analysis denominator · Participants
Group
Source count
TAS-102+BSC
0
Placebo+BSC
1
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Placebo+BSC
33.3
Not reported
Not reported
Not reported
Not reported
Cycle 15
Analysis denominator · Participants
Group
Source count
TAS-102+BSC
0
Placebo+BSC
1
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Placebo+BSC
33.3
Not reported
Not reported
Not reported
Not reported
Last Collection Cycle
Analysis denominator · Participants
Group
Source count
TAS-102+BSC
283
Placebo+BSC
128
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
TAS-102+BSC
-8.8
20.91
Not reported
Not reported
Not reported
Placebo+BSC
-9.8
25.34
Not reported
Not reported
Not reported
Safety Follow-Up
Analysis denominator · Participants
Group
Source count
TAS-102+BSC
39
Placebo+BSC
14
Values in units on a scale · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
TAS-102+BSC
-16.5
23.45
Not reported
Not reported
Not reported
Placebo+BSC
-8.9
18.33
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
17.56
value
-2.7
group Id
OG001
spread
22.20
value
-5.9
denoms
counts
group Id
OG000
value
279
group Id
OG001
value
127
units
Participants
title
Cycle 1
categories
measurements
group Id
OG000
spread
20.51
value
-5.9
group Id
OG001
spread
25.80
value
-7.3
denoms
counts
group Id
OG000
value
187
group Id
OG001
value
58
units
Participants
title
Cycle 2
categories
measurements
group Id
OG000
spread
18.26
value
-4.1
group Id
OG001
spread
22.00
value
-1.4
denoms
counts
group Id
OG000
value
121
group Id
OG001
value
23
units
Participants
title
Cycle 3
categories
measurements
group Id
OG000
spread
17.54
value
-3.6
group Id
OG001
spread
22.32
value
-1.7
denoms
counts
group Id
OG000
value
79
group Id
OG001
value
15
units
Participants
title
Cycle 4
categories
measurements
group Id
OG000
spread
18.05
value
-5.9
group Id
OG001
spread
18.16
value
11.1
denoms
counts
group Id
OG000
value
55
group Id
OG001
value
9
units
Participants
title
Cycle 5
categories
measurements
group Id
OG000
spread
23.05
value
-8.8
group Id
OG001
spread
21.10
value
15.6
denoms
counts
group Id
OG000
value
36
group Id
OG001
value
8
units
Participants
title
Cycle 6
categories
measurements
group Id
OG000
spread
21.96
value
-9.5
group Id
OG001
spread
4.56
value
20.0
denoms
counts
group Id
OG000
value
28
group Id
OG001
value
5
units
Participants
title
Cycle 7
categories
measurements
group Id
OG000
spread
23.82
value
-4.3
group Id
OG001
spread
11.79
value
16.7
denoms
counts
group Id
OG000
value
23
group Id
OG001
value
5
units
Participants
title
Cycle 8
categories
measurements
group Id
OG000
spread
17.12
value
2.4
group Id
OG001
spread
16.67
value
16.7
denoms
counts
group Id
OG000
value
14
group Id
OG001
value
3
units
Participants
title
Cycle 9
categories
measurements
group Id
OG000
spread
25.57
value
-14.4
group Id
OG001
spread
11.79
value
25.0
denoms
counts
group Id
OG000
value
11
group Id
OG001
value
2
units
Participants
title
Cycle 10
categories
measurements
group Id
OG000
spread
37.27
value
-16.7
group Id
OG001
spread
11.79
value
25.0
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
2
units
Participants
title
Cycle 11
categories
measurements
group Id
OG000
spread
11.79
value
-8.3
group Id
OG001
value
33.3
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
1
units
Participants
title
Cycle 12
denoms
counts
group Id
OG000
value
337
group Id
OG001
value
170
units
Participants
description
EORTC-QLQ-C30 is a cancer-specific instrument with 30 questions for evaluation of new chemotherapy and provides an assessment of participant reported outcome dimensions. First 28 questions used 4-point scale (1=not at all,2=a little,3=quite a bit,4=very much) for evaluating 5 functional scales (physical,role,emotional,cognitive,social), 3 symptom scales (fatigue,nausea/vomiting,pain) and other single items. For each item,high score represented high level of symptomatology/problem. Last 2 questions represented participant's assessment of overall health and QoL, coded on 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 observed values and change from baseline for global health status (scoring of questions 29 and 30) and 5 functional scales, 3 symptom scales and other single items (scoring of questions 1 to 28). Answers were converted into grading scale, with values between 0 and 100. A high score represented a favorable outcome with a best QoL for participant.
dispersion Type
Standard Deviation
groups
description
Participants received 35 mg/m\^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
id
OG000
title
TAS-102+BSC
description
Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
id
OG001
title
Placebo+BSC
param Type
MEAN
population Description
Analysis was performed on the ITT population that included all randomized participants, regardless of whether or not study treatment was administered. Here, 'number analyzed' = participants with available data for each specified category.
reporting Status
POSTED
time Frame
Baseline, Day 1 Cycle 2 up to end of treatment (EOT) (within 30 days of last study treatment) and 30-Day safety follow-up visit (maximum duration: up to approximately 46 months)
title
Change From Baseline in Quality of Life European Organization for Research and Treatment for Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30 Score): Global Health Status
Triangle