Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)
Study of IMC-1121B (Ramucirumab) With Best Supportive Care in Participants With Gastric Cancer and Adenocarcinoma · Source last updated 2019-09-25
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
LEAST_SQUARES_MEAN
Unit
units on a scale
Interval / dispersion
Standard Error
Time frame
Baseline up to Cycle 10 (18 weeks [1 cycle=2 weeks])
What was measured
EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms. Best change from baseline results determined by Least Square (LS) mean estimated with randomization stratification factors and baseline value as continuous covariate.
Analysis population: All randomized participants with EORTC QLQ-C30 values at baseline and any point up to 18 weeks post-baseline.
Groups in this outcome
IMC-1121B (Ramucirumab)
Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
Placebo
Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
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
IMC-1121B (Ramucirumab)
114
Placebo
26
Reported measurements
Global Health Status/QoL
Values in units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
IMC-1121B (Ramucirumab)
2.42
2.99
Not reported
Not reported
Not reported
Placebo
0.80
4.48
Not reported
Not reported
Not reported
Physical Functioning
Values in units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
IMC-1121B (Ramucirumab)
-6.26
3.20
Not reported
Not reported
Not reported
Placebo
-12.01
4.82
Not reported
Not reported
Not reported
Role Functioning
Values in units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
IMC-1121B (Ramucirumab)
-4.32
4.65
Not reported
Not reported
Not reported
Placebo
-11.79
6.99
Not reported
Not reported
Not reported
Emotional Functioning
Values in units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
IMC-1121B (Ramucirumab)
-1.61
3.29
Not reported
Not reported
Not reported
Placebo
-6.51
4.92
Not reported
Not reported
Not reported
Cognitive Functioning
Values in units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
IMC-1121B (Ramucirumab)
-4.26
2.63
Not reported
Not reported
Not reported
Placebo
-10.94
3.94
Not reported
Not reported
Not reported
Social Functioning
Values in units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
IMC-1121B (Ramucirumab)
-1.98
3.90
Not reported
Not reported
Not reported
Placebo
-1.37
5.86
Not reported
Not reported
Not reported
Fatigue
Values in units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
IMC-1121B (Ramucirumab)
3.16
3.43
Not reported
Not reported
Not reported
Placebo
6.88
5.16
Not reported
Not reported
Not reported
Nausea and Vomiting
Values in units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
IMC-1121B (Ramucirumab)
1.77
2.86
Not reported
Not reported
Not reported
Placebo
2.88
4.32
Not reported
Not reported
Not reported
Pain
Values in units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
IMC-1121B (Ramucirumab)
0.13
3.61
Not reported
Not reported
Not reported
Placebo
3.85
5.42
Not reported
Not reported
Not reported
Dyspnea
Values in units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
IMC-1121B (Ramucirumab)
-2.61
3.35
Not reported
Not reported
Not reported
Placebo
3.51
5.08
Not reported
Not reported
Not reported
Insomnia
Values in units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
IMC-1121B (Ramucirumab)
-7.47
4.19
Not reported
Not reported
Not reported
Placebo
-3.95
6.28
Not reported
Not reported
Not reported
Appetite Loss
Values in units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
IMC-1121B (Ramucirumab)
-1.01
4.60
Not reported
Not reported
Not reported
Placebo
7.16
6.91
Not reported
Not reported
Not reported
Constipation
Values in units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
IMC-1121B (Ramucirumab)
0.09
3.79
Not reported
Not reported
Not reported
Placebo
7.94
5.69
Not reported
Not reported
Not reported
Diarrhea
Values in units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
IMC-1121B (Ramucirumab)
-3.97
1.64
Not reported
Not reported
Not reported
Placebo
-5.49
2.46
Not reported
Not reported
Not reported
Financial Difficulties
Values in units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
IMC-1121B (Ramucirumab)
-12.86
3.78
Not reported
Not reported
Not reported
Placebo
-2.39
5.68
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
2.99
value
2.42
group Id
OG001
spread
4.48
value
0.80
title
Global Health Status/QoL
categories
measurements
group Id
OG000
spread
3.20
value
-6.26
group Id
OG001
spread
4.82
value
-12.01
title
Physical Functioning
categories
measurements
group Id
OG000
spread
4.65
value
-4.32
group Id
OG001
spread
6.99
value
-11.79
title
Role Functioning
categories
measurements
group Id
OG000
spread
3.29
value
-1.61
group Id
OG001
spread
4.92
value
-6.51
title
Emotional Functioning
categories
measurements
group Id
OG000
spread
2.63
value
-4.26
group Id
OG001
spread
3.94
value
-10.94
title
Cognitive Functioning
categories
measurements
group Id
OG000
spread
3.90
value
-1.98
group Id
OG001
spread
5.86
value
-1.37
title
Social Functioning
categories
measurements
group Id
OG000
spread
3.43
value
3.16
group Id
OG001
spread
5.16
value
6.88
title
Fatigue
categories
measurements
group Id
OG000
spread
2.86
value
1.77
group Id
OG001
spread
4.32
value
2.88
title
Nausea and Vomiting
categories
measurements
group Id
OG000
spread
3.61
value
0.13
group Id
OG001
spread
5.42
value
3.85
title
Pain
categories
measurements
group Id
OG000
spread
3.35
value
-2.61
group Id
OG001
spread
5.08
value
3.51
title
Dyspnea
categories
measurements
group Id
OG000
spread
4.19
value
-7.47
group Id
OG001
spread
6.28
value
-3.95
title
Insomnia
categories
measurements
group Id
OG000
spread
4.60
value
-1.01
group Id
OG001
spread
6.91
value
7.16
title
Appetite Loss
denoms
counts
group Id
OG000
value
114
group Id
OG001
value
26
units
Participants
description
EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms. Best change from baseline results determined by Least Square (LS) mean estimated with randomization stratification factors and baseline value as continuous covariate.
dispersion Type
Standard Error
groups
description
Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
id
OG000
title
IMC-1121B (Ramucirumab)
description
Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
id
OG001
title
Placebo
param Type
LEAST_SQUARES_MEAN
population Description
All randomized participants with EORTC QLQ-C30 values at baseline and any point up to 18 weeks post-baseline.
reporting Status
POSTED
time Frame
Baseline up to Cycle 10 (18 weeks [1 cycle=2 weeks])
title
Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)
Triangle