TriangleNCT02654990 · OUTCOME
Change From Baseline in European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Core 30-item Questionnaire (QLQ-C30) Global Health Status (GHS) Score
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- score on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycle 15 Day 1, at approximately 295 days
What was measured
Health-related quality of life (HRQoL) was assessed by the EORTC QLQ-C30, which is frequently employed in clinical oncology trials and is recognized as reliable and valid. The EORTC QLQ-C30 measures functional dimensions (physical, role, emotional, cognitive, and social), 3 symptom items (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact), and a global health scale (GHS) and quality-of-life scale. For each domain and item, a linear transformation is applied to standardize the score between 0 and 100. Results are presented specifically for the GHS score. A higher GHS score indicates a higher HRQoL. Each cycle was 21 days long.
Analysis population: Full analysis set (FAS): all participants to whom study treatment was assigned by randomization and who had a valid baseline HRQoL assessment and at least 1 post-baseline assessment. Here, 'Overall Number of Participants Analyzed' refers to the number of evaluable participants analyzed.
Groups in this outcome
Arm A - Panobinostat (20 mg, TIW)
Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
Arm B - Panobinostat (20 mg, BIW)
Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
Arm C - Panobinostat (10 mg, TIW)
Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
| Group | Source count |
|---|---|
| Arm A - Panobinostat (20 mg, TIW) | 18 |
| Arm B - Panobinostat (20 mg, BIW) | 16 |
| Arm C - Panobinostat (10 mg, TIW) | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A - Panobinostat (20 mg, TIW) | 6.0 | 23.01 | Not reported | Not reported | Not reported |
| Arm B - Panobinostat (20 mg, BIW) | 0.0 | 30.12 | Not reported | Not reported | Not reported |
| Arm C - Panobinostat (10 mg, TIW) | -4.6 | 24.12 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 23.01
- value
- 6.0
- group Id
- OG001
- spread
- 30.12
- value
- 0.0
- group Id
- OG002
- spread
- 24.12
- value
- -4.6
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 18
- units
- Participants
- description
- Health-related quality of life (HRQoL) was assessed by the EORTC QLQ-C30, which is frequently employed in clinical oncology trials and is recognized as reliable and valid. The EORTC QLQ-C30 measures functional dimensions (physical, role, emotional, cognitive, and social), 3 symptom items (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact), and a global health scale (GHS) and quality-of-life scale. For each domain and item, a linear transformation is applied to standardize the score between 0 and 100. Results are presented specifically for the GHS score. A higher GHS score indicates a higher HRQoL. Each cycle was 21 days long.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
- id
- OG000
- title
- Arm A - Panobinostat (20 mg, TIW)
- description
- Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
- id
- OG001
- title
- Arm B - Panobinostat (20 mg, BIW)
- description
- Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
- id
- OG002
- title
- Arm C - Panobinostat (10 mg, TIW)
- param Type
- MEAN
- population Description
- Full analysis set (FAS): all participants to whom study treatment was assigned by randomization and who had a valid baseline HRQoL assessment and at least 1 post-baseline assessment. Here, 'Overall Number of Participants Analyzed' refers to the number of evaluable participants analyzed.
- reporting Status
- POSTED
- time Frame
- Cycle 15 Day 1, at approximately 295 days
- title
- Change From Baseline in European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Core 30-item Questionnaire (QLQ-C30) Global Health Status (GHS) Score
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice