TriangleNCT02853331 · OUTCOME
Least Squares (LS) Mean Change From Baseline to Week 30 in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score
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
- 95% Confidence Interval
- Time frame
- Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days]) and Week 30
What was measured
EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall quality of life (QOL) in cancer participants. The first 28 questions used a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting \[N/V\], constipation, and pain) and a single item (financial difficulties). The last 2 questions represented the participant's assessment of overall health and quality of life on a 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 global scores were linearly transformed on a scale of 0 to 100; with a high score indicating improved health status. Negative change from baseline values indicated deterioration in health status or functioning and positive changes indicated improvement. The LS Mean change from baseline to Week 30 is presented.
Analysis population: All participants who received at least 1 dose of study medication and had non-missing questionnaire assessments at baseline and Week 30.
Groups in this outcome
Pembrolizumab + Axitinib
Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.
Sunitinib
Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
| Group | Source count |
|---|---|
| Pembrolizumab + Axitinib | 427 |
| Sunitinib | 423 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab + Axitinib | -4.05 | Not reported | -6.03 | -2.07 | Not reported |
| Sunitinib | -2.35 | Not reported | -4.44 | -0.26 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -6.03
- upper Limit
- -2.07
- value
- -4.05
- group Id
- OG001
- lower Limit
- -4.44
- upper Limit
- -0.26
- value
- -2.35
- denoms
- counts
- group Id
- OG000
- value
- 427
- group Id
- OG001
- value
- 423
- units
- Participants
- description
- EORTC QLQ-C30 is a cancer-specific instrument with 30 questions used to assess the overall quality of life (QOL) in cancer participants. The first 28 questions used a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) for evaluating 5 functional scales (physical, role, social, cognitive, emotional), 8 symptom scales/items (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea and vomiting \[N/V\], constipation, and pain) and a single item (financial difficulties). The last 2 questions represented the participant's assessment of overall health and quality of life on a 7-point scale (1=very poor to 7=excellent). EORTC QLQ-C30 global scores were linearly transformed on a scale of 0 to 100; with a high score indicating improved health status. Negative change from baseline values indicated deterioration in health status or functioning and positive changes indicated improvement. The LS Mean change from baseline to Week 30 is presented.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.
- id
- OG000
- title
- Pembrolizumab + Axitinib
- description
- Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
- id
- OG001
- title
- Sunitinib
- param Type
- LEAST_SQUARES_MEAN
- population Description
- All participants who received at least 1 dose of study medication and had non-missing questionnaire assessments at baseline and Week 30.
- reporting Status
- POSTED
- time Frame
- Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days]) and Week 30
- title
- Least Squares (LS) Mean Change From Baseline to Week 30 in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score
- type
- POST_HOC
- unit Of Measure
- Score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice