Change From Baseline to Short Term Follow up in Quality of Life Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer · Source last updated 2025-10-21
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, Short Term Follow Up (Up To 31 Months)
What was measured
EORTC QLQ-C30 v3.0 was 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, scores range from 0 to 110 with higher scores representing a better level of functioning. For symptoms scales, scores range from 0 to 100 with higher scores representing a greater degree of symptoms. LS Mean value of changing from baseline to short follow up was estimated from the mixed model that was controlled for Treatment, visit, Treatment\*Visit and baseline.
Analysis population: All randomized participants who received at least one dose of study drug with baseline and post-baseline EORTC QLQ-C30 data at short term follow up for each EORTC QLQ-C30 items.
Groups in this outcome
Abemaciclib + Fulvestrant
Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
Placebo + Fulvestrant
Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were 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
Abemaciclib + Fulvestrant
180
Placebo + Fulvestrant
126
Reported measurements
Global health status
Analysis denominator · Participants
Group
Source count
Abemaciclib + Fulvestrant
179
Placebo + Fulvestrant
126
Values in units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Abemaciclib + Fulvestrant
-4.57
1.55
Not reported
Not reported
Not reported
Placebo + Fulvestrant
-8.15
1.87
Not reported
Not reported
Not reported
Functional scale: Physical functioning
Analysis denominator · Participants
Group
Source count
Abemaciclib + Fulvestrant
179
Placebo + Fulvestrant
126
Values in units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Abemaciclib + Fulvestrant
-3.76
1.29
Not reported
Not reported
Not reported
Placebo + Fulvestrant
-7.59
1.59
Not reported
Not reported
Not reported
Functional scale: Role functioning
Analysis denominator · Participants
Group
Source count
Abemaciclib + Fulvestrant
179
Placebo + Fulvestrant
124
Values in units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Abemaciclib + Fulvestrant
-4.87
1.73
Not reported
Not reported
Not reported
Placebo + Fulvestrant
-9.58
2.12
Not reported
Not reported
Not reported
Functional scale: Emotional functioning
Analysis denominator · Participants
Group
Source count
Abemaciclib + Fulvestrant
179
Placebo + Fulvestrant
125
Values in units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Abemaciclib + Fulvestrant
2.38
1.38
Not reported
Not reported
Not reported
Placebo + Fulvestrant
-2.44
1.70
Not reported
Not reported
Not reported
Functional scale: Cognitive functioning
Analysis denominator · Participants
Group
Source count
Abemaciclib + Fulvestrant
180
Placebo + Fulvestrant
125
Values in units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Abemaciclib + Fulvestrant
-3.16
1.29
Not reported
Not reported
Not reported
Placebo + Fulvestrant
-2.96
1.58
Not reported
Not reported
Not reported
Functional scale: Social functioning
Analysis denominator · Participants
Group
Source count
Abemaciclib + Fulvestrant
180
Placebo + Fulvestrant
126
Values in units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Abemaciclib + Fulvestrant
-4.62
1.61
Not reported
Not reported
Not reported
Placebo + Fulvestrant
-4.78
1.97
Not reported
Not reported
Not reported
Symptom scale: Fatigue
Analysis denominator · Participants
Group
Source count
Abemaciclib + Fulvestrant
180
Placebo + Fulvestrant
125
Values in units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Abemaciclib + Fulvestrant
5.01
1.45
Not reported
Not reported
Not reported
Placebo + Fulvestrant
7.83
1.78
Not reported
Not reported
Not reported
Symptom scale: Nausea and vomiting
Analysis denominator · Participants
Group
Source count
Abemaciclib + Fulvestrant
180
Placebo + Fulvestrant
125
Values in units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Abemaciclib + Fulvestrant
2.81
1.35
Not reported
Not reported
Not reported
Placebo + Fulvestrant
6.49
1.64
Not reported
Not reported
Not reported
Symptom scale: Pain
Analysis denominator · Participants
Group
Source count
Abemaciclib + Fulvestrant
180
Placebo + Fulvestrant
126
Values in units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Abemaciclib + Fulvestrant
-0.47
1.82
Not reported
Not reported
Not reported
Placebo + Fulvestrant
4.38
2.21
Not reported
Not reported
Not reported
Symptom scale: Dyspnoea
Analysis denominator · Participants
Group
Source count
Abemaciclib + Fulvestrant
180
Placebo + Fulvestrant
123
Values in units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Abemaciclib + Fulvestrant
5.21
1.70
Not reported
Not reported
Not reported
Placebo + Fulvestrant
5.39
2.10
Not reported
Not reported
Not reported
Symptom scale: Insomnia
Analysis denominator · Participants
Group
Source count
Abemaciclib + Fulvestrant
180
Placebo + Fulvestrant
126
Values in units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Abemaciclib + Fulvestrant
-0.04
1.86
Not reported
Not reported
Not reported
Placebo + Fulvestrant
3.76
2.27
Not reported
Not reported
Not reported
Symptom scale: Appetite loss
Analysis denominator · Participants
Group
Source count
Abemaciclib + Fulvestrant
180
Placebo + Fulvestrant
125
Values in units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Abemaciclib + Fulvestrant
2.06
1.85
Not reported
Not reported
Not reported
Placebo + Fulvestrant
6.40
2.23
Not reported
Not reported
Not reported
Symptom scale: Constipation
Analysis denominator · Participants
Group
Source count
Abemaciclib + Fulvestrant
179
Placebo + Fulvestrant
125
Values in units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Abemaciclib + Fulvestrant
-0.15
1.59
Not reported
Not reported
Not reported
Placebo + Fulvestrant
3.79
1.92
Not reported
Not reported
Not reported
Symptom scale: Diarrhoea
Analysis denominator · Participants
Group
Source count
Abemaciclib + Fulvestrant
179
Placebo + Fulvestrant
125
Values in units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Abemaciclib + Fulvestrant
4.14
1.66
Not reported
Not reported
Not reported
Placebo + Fulvestrant
2.67
1.99
Not reported
Not reported
Not reported
Symptom scale: Financial difficulties
Analysis denominator · Participants
Group
Source count
Abemaciclib + Fulvestrant
179
Placebo + Fulvestrant
124
Values in units on a scale · Interval/dispersion: Standard Error
Group
Value
Spread
Lower
Upper
Comment
Abemaciclib + Fulvestrant
0.34
1.60
Not reported
Not reported
Not reported
Placebo + Fulvestrant
2.85
1.96
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
1.55
value
-4.57
group Id
OG001
spread
1.87
value
-8.15
denoms
counts
group Id
OG000
value
179
group Id
OG001
value
126
units
Participants
title
Global health status
categories
measurements
group Id
OG000
spread
1.29
value
-3.76
group Id
OG001
spread
1.59
value
-7.59
denoms
counts
group Id
OG000
value
179
group Id
OG001
value
126
units
Participants
title
Functional scale: Physical functioning
categories
measurements
group Id
OG000
spread
1.73
value
-4.87
group Id
OG001
spread
2.12
value
-9.58
denoms
counts
group Id
OG000
value
179
group Id
OG001
value
124
units
Participants
title
Functional scale: Role functioning
categories
measurements
group Id
OG000
spread
1.38
value
2.38
group Id
OG001
spread
1.70
value
-2.44
denoms
counts
group Id
OG000
value
179
group Id
OG001
value
125
units
Participants
title
Functional scale: Emotional functioning
categories
measurements
group Id
OG000
spread
1.29
value
-3.16
group Id
OG001
spread
1.58
value
-2.96
denoms
counts
group Id
OG000
value
180
group Id
OG001
value
125
units
Participants
title
Functional scale: Cognitive functioning
categories
measurements
group Id
OG000
spread
1.61
value
-4.62
group Id
OG001
spread
1.97
value
-4.78
denoms
counts
group Id
OG000
value
180
group Id
OG001
value
126
units
Participants
title
Functional scale: Social functioning
categories
measurements
group Id
OG000
spread
1.45
value
5.01
group Id
OG001
spread
1.78
value
7.83
denoms
counts
group Id
OG000
value
180
group Id
OG001
value
125
units
Participants
title
Symptom scale: Fatigue
categories
measurements
group Id
OG000
spread
1.35
value
2.81
group Id
OG001
spread
1.64
value
6.49
denoms
counts
group Id
OG000
value
180
group Id
OG001
value
125
units
Participants
title
Symptom scale: Nausea and vomiting
categories
measurements
group Id
OG000
spread
1.82
value
-0.47
group Id
OG001
spread
2.21
value
4.38
denoms
counts
group Id
OG000
value
180
group Id
OG001
value
126
units
Participants
title
Symptom scale: Pain
categories
measurements
group Id
OG000
spread
1.70
value
5.21
group Id
OG001
spread
2.10
value
5.39
denoms
counts
group Id
OG000
value
180
group Id
OG001
value
123
units
Participants
title
Symptom scale: Dyspnoea
categories
measurements
group Id
OG000
spread
1.86
value
-0.04
group Id
OG001
spread
2.27
value
3.76
denoms
counts
group Id
OG000
value
180
group Id
OG001
value
126
units
Participants
title
Symptom scale: Insomnia
categories
measurements
group Id
OG000
spread
1.85
value
2.06
group Id
OG001
spread
2.23
value
6.40
denoms
counts
group Id
OG000
value
180
group Id
OG001
value
125
units
Participants
title
Symptom scale: Appetite loss
denoms
counts
group Id
OG000
value
180
group Id
OG001
value
126
units
Participants
description
EORTC QLQ-C30 v3.0 was 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, scores range from 0 to 110 with higher scores representing a better level of functioning. For symptoms scales, scores range from 0 to 100 with higher scores representing a greater degree of symptoms. LS Mean value of changing from baseline to short follow up was estimated from the mixed model that was controlled for Treatment, visit, Treatment\*Visit and baseline.
dispersion Type
Standard Error
groups
description
Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
id
OG000
title
Abemaciclib + Fulvestrant
description
Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
id
OG001
title
Placebo + Fulvestrant
param Type
LEAST_SQUARES_MEAN
population Description
All randomized participants who received at least one dose of study drug with baseline and post-baseline EORTC QLQ-C30 data at short term follow up for each EORTC QLQ-C30 items.
reporting Status
POSTED
time Frame
Baseline, Short Term Follow Up (Up To 31 Months)
title
Change From Baseline to Short Term Follow up in Quality of Life Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Triangle