NCT02246621 · OUTCOME
Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-C30 Symptom Scale Scores
A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer · Source last updated 2026-02-03
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, End of Study (Up to 32 Months)
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. Symptom scale ranges from: 1, "Not at all"; 2, "A little"; 3, "Quite a bit"; to 4, "Very much." A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For symptoms scales, higher scores indicated greater symptom burden. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, Visit, Treatment\*Visit and Baseline. Small changes are generally defined as at least a 3, 4 or 5 point change from baseline.
Analysis population: All randomized participants.
Groups in this outcome
Abemaciclib + NSAI
150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Placebo + NSAI
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
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 + NSAI | 328 |
|---|
| Placebo + NSAI | 165 |
|---|
Reported measurements
Fatigue
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Abemaciclib + NSAI | 2.4 | 1.0 | Not reported | Not reported | Not reported |
|---|
| Placebo + NSAI | -2.6 | 1.4 | Not reported | Not reported | Not reported |
|---|
Nausea and Vomiting
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Abemaciclib + NSAI | 2.4 | 0.6 | Not reported | Not reported | Not reported |
|---|
| Placebo + NSAI | -0.4 | 0.9 | Not reported | Not reported | Not reported |
|---|
Pain
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Abemaciclib + NSAI | -4.8 | 1.0 | Not reported | Not reported | Not reported |
|---|
| Placebo + NSAI | -5.7 | 1.5 | Not reported | Not reported | Not reported |
|---|
Dyspnea
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Abemaciclib + NSAI | 0.9 | 1.0 | Not reported | Not reported | Not reported |
|---|
| Placebo + NSAI | -1.6 | 1.4 | Not reported | Not reported | Not reported |
|---|
Insomnia
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Abemaciclib + NSAI | -1.7 | 1.2 | Not reported | Not reported | Not reported |
|---|
| Placebo + NSAI | -4.1 | 1.7 | Not reported | Not reported | Not reported |
|---|
Appetite loss
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Abemaciclib + NSAI | 0.2 | 1.1 | Not reported | Not reported | Not reported |
|---|
| Placebo + NSAI | -3.9 | 1.6 | Not reported | Not reported | Not reported |
|---|
Constipation
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Abemaciclib + NSAI | -0.8 | 0.9 | Not reported | Not reported | Not reported |
|---|
| Placebo + NSAI | 1.6 | 1.3 | Not reported | Not reported | Not reported |
|---|
Diarrhea
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Abemaciclib + NSAI | 18.2 | 1.0 | Not reported | Not reported | Not reported |
|---|
| Placebo + NSAI | -0.5 | 1.5 | Not reported | Not reported | Not reported |
|---|
Financial difficulties
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Abemaciclib + NSAI | -0.7 | 1.1 | Not reported | Not reported | Not reported |
|---|
| Placebo + NSAI | -1.2 | 1.6 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.0
- value
- 2.4
- group Id
- OG001
- spread
- 1.4
- value
- -2.6
- title
- Fatigue
- categories
- measurements
- group Id
- OG000
- spread
- 0.6
- value
- 2.4
- group Id
- OG001
- spread
- 0.9
- value
- -0.4
- title
- Nausea and Vomiting
- categories
- measurements
- group Id
- OG000
- spread
- 1.0
- value
- -4.8
- group Id
- OG001
- spread
- 1.5
- value
- -5.7
- title
- Pain
- categories
- measurements
- group Id
- OG000
- spread
- 1.0
- value
- 0.9
- group Id
- OG001
- spread
- 1.4
- value
- -1.6
- title
- Dyspnea
- categories
- measurements
- group Id
- OG000
- spread
- 1.2
- value
- -1.7
- group Id
- OG001
- spread
- 1.7
- value
- -4.1
- title
- Insomnia
- categories
- measurements
- group Id
- OG000
- spread
- 1.1
- value
- 0.2
- group Id
- OG001
- spread
- 1.6
- value
- -3.9
- title
- Appetite loss
- categories
- measurements
- group Id
- OG000
- spread
- 0.9
- value
- -0.8
- group Id
- OG001
- spread
- 1.3
- value
- 1.6
- title
- Constipation
- categories
- measurements
- group Id
- OG000
- spread
- 1.0
- value
- 18.2
- group Id
- OG001
- spread
- 1.5
- value
- -0.5
- title
- Diarrhea
- categories
- measurements
- group Id
- OG000
- spread
- 1.1
- value
- -0.7
- group Id
- OG001
- spread
- 1.6
- value
- -1.2
- title
- Financial difficulties
- denoms
- counts
- group Id
- OG000
- value
- 328
- group Id
- OG001
- value
- 165
- 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. Symptom scale ranges from: 1, "Not at all"; 2, "A little"; 3, "Quite a bit"; to 4, "Very much." A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For symptoms scales, higher scores indicated greater symptom burden. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, Visit, Treatment\*Visit and Baseline. Small changes are generally defined as at least a 3, 4 or 5 point change from baseline.
- dispersion Type
- Standard Error
- groups
- description
- 150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
- id
- OG000
- title
- Abemaciclib + NSAI
- description
- Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
- id
- OG001
- title
- Placebo + NSAI
- param Type
- LEAST_SQUARES_MEAN
- population Description
- All randomized participants.
- reporting Status
- POSTED
- time Frame
- Baseline, End of Study (Up to 32 Months)
- title
- Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-C30 Symptom Scale Scores
- type
- SECONDARY
- unit Of Measure
- score on a scale
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