TriangleNCT02246621 · OUTCOME
Change From Baseline to End of Study in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Functional Scale Scores
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.Functional scale options are defined on a 7-point scale ranging from 1, "Very poor" to 7, "Excellent". A linear transformation is applied to standardize the raw scores to range between 0 and 100 with higher score indicating better functioning. For functional domains and global health status, higher scores represent a better level of functioning. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, Visit, Treatment\*Visit and 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 | Source count |
|---|---|
| Abemaciclib + NSAI | 328 |
| Placebo + NSAI | 165 |
Reported measurements
Physical
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Abemaciclib + NSAI | -1.0 | 0.9 | Not reported | Not reported | Not reported |
| Placebo + NSAI | 1.7 | 1.2 | Not reported | Not reported | Not reported |
Role
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Abemaciclib + NSAI | -1.4 | 1.1 | Not reported | Not reported | Not reported |
| Placebo + NSAI | 2.9 | 1.6 | Not reported | Not reported | Not reported |
Emotional
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Abemaciclib + NSAI | 4.7 | 0.9 | Not reported | Not reported | Not reported |
| Placebo + NSAI | 4.0 | 1.3 | Not reported | Not reported | Not reported |
Cognitive
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Abemaciclib + NSAI | -4.0 | 0.9 | Not reported | Not reported | Not reported |
| Placebo + NSAI | -4.0 | 1.3 | Not reported | Not reported | Not reported |
Social
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Abemaciclib + NSAI | -0.1 | 1.0 | Not reported | Not reported | Not reported |
| Placebo + NSAI | 3.3 | 1.4 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.9
- value
- -1.0
- group Id
- OG001
- spread
- 1.2
- value
- 1.7
- title
- Physical
- categories
- measurements
- group Id
- OG000
- spread
- 1.1
- value
- -1.4
- group Id
- OG001
- spread
- 1.6
- value
- 2.9
- title
- Role
- categories
- measurements
- group Id
- OG000
- spread
- 0.9
- value
- 4.7
- group Id
- OG001
- spread
- 1.3
- value
- 4.0
- title
- Emotional
- categories
- measurements
- group Id
- OG000
- spread
- 0.9
- value
- -4.0
- group Id
- OG001
- spread
- 1.3
- value
- -4.0
- title
- Cognitive
- categories
- measurements
- group Id
- OG000
- spread
- 1.0
- value
- -0.1
- group Id
- OG001
- spread
- 1.4
- value
- 3.3
- title
- Social
- 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.Functional scale options are defined on a 7-point scale ranging from 1, "Very poor" to 7, "Excellent". A linear transformation is applied to standardize the raw scores to range between 0 and 100 with higher score indicating better functioning. For functional domains and global health status, higher scores represent a better level of functioning. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, Visit, Treatment\*Visit and 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 European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Functional Scale Scores
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice