TriangleNCT00507416 · OUTCOME
Change From Baseline in EORTC QLQ-C30 - Global Health Status
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline and Day 1 of Cycles 3, 5, 7, 9, 11 and 13
What was measured
The European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL Scale is scored between 0 and 100, where higher scores indicate better Global Health Status/QOL. Negative changes from baseline indicate deterioration in QOL or functioning and positive changes indicate improvement.
Analysis population: Intent-to-treat population with available data at each time point (indicated by "n").
Groups in this outcome
Bortezomib and Dexamethasone
Participants received bortezomib (Velcade) 1.3 mg/m\^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Bortezomib, Thalidomide, and Dexamethasone
Participants received bortezomib 1.3 mg/m\^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
Bortezomib, Melphalan and Prednisone
Participants received bortezomib 1.3 mg/m\^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m\^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m\^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
| Group | Source count |
|---|---|
| Bortezomib and Dexamethasone | 168 |
| Bortezomib, Thalidomide, and Dexamethasone | 167 |
| Bortezomib, Melphalan and Prednisone | 167 |
Reported measurements
Cycle 3, Day 1 (n=129, 115, 125)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bortezomib and Dexamethasone | 1.3 | 25.40 | Not reported | Not reported | Not reported |
| Bortezomib, Thalidomide, and Dexamethasone | -4.4 | 27.04 | Not reported | Not reported | Not reported |
| Bortezomib, Melphalan and Prednisone | 2.0 | 30.82 | Not reported | Not reported | Not reported |
Cycle 5, Day 1 (n=114, 98, 107)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bortezomib and Dexamethasone | -4.9 | 30.36 | Not reported | Not reported | Not reported |
| Bortezomib, Thalidomide, and Dexamethasone | -6.1 | 27.47 | Not reported | Not reported | Not reported |
| Bortezomib, Melphalan and Prednisone | -0.4 | 29.24 | Not reported | Not reported | Not reported |
Cycle 7, Day 1 (n=89, 79, 84)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bortezomib and Dexamethasone | -3.3 | 32.58 | Not reported | Not reported | Not reported |
| Bortezomib, Thalidomide, and Dexamethasone | -8.6 | 31.86 | Not reported | Not reported | Not reported |
| Bortezomib, Melphalan and Prednisone | -4.7 | 28.61 | Not reported | Not reported | Not reported |
Cycle 9, Day 1 (n=87, 66, 67)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bortezomib and Dexamethasone | -4.2 | 33.55 | Not reported | Not reported | Not reported |
| Bortezomib, Thalidomide, and Dexamethasone | -8.1 | 28.16 | Not reported | Not reported | Not reported |
| Bortezomib, Melphalan and Prednisone | -1.0 | 28.55 | Not reported | Not reported | Not reported |
Cycle 11, Day 1 (n=71, 61, 65)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bortezomib and Dexamethasone | -11.6 | 33.67 | Not reported | Not reported | Not reported |
| Bortezomib, Thalidomide, and Dexamethasone | -7.9 | 29.54 | Not reported | Not reported | Not reported |
| Bortezomib, Melphalan and Prednisone | 2.8 | 31.72 | Not reported | Not reported | Not reported |
Cycle 13, Day 1 (n=67, 52, 61)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bortezomib and Dexamethasone | -10.2 | 36.00 | Not reported | Not reported | Not reported |
| Bortezomib, Thalidomide, and Dexamethasone | -8.5 | 32.87 | Not reported | Not reported | Not reported |
| Bortezomib, Melphalan and Prednisone | 1.0 | 35.16 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 25.40
- value
- 1.3
- group Id
- OG001
- spread
- 27.04
- value
- -4.4
- group Id
- OG002
- spread
- 30.82
- value
- 2.0
- title
- Cycle 3, Day 1 (n=129, 115, 125)
- categories
- measurements
- group Id
- OG000
- spread
- 30.36
- value
- -4.9
- group Id
- OG001
- spread
- 27.47
- value
- -6.1
- group Id
- OG002
- spread
- 29.24
- value
- -0.4
- title
- Cycle 5, Day 1 (n=114, 98, 107)
- categories
- measurements
- group Id
- OG000
- spread
- 32.58
- value
- -3.3
- group Id
- OG001
- spread
- 31.86
- value
- -8.6
- group Id
- OG002
- spread
- 28.61
- value
- -4.7
- title
- Cycle 7, Day 1 (n=89, 79, 84)
- categories
- measurements
- group Id
- OG000
- spread
- 33.55
- value
- -4.2
- group Id
- OG001
- spread
- 28.16
- value
- -8.1
- group Id
- OG002
- spread
- 28.55
- value
- -1.0
- title
- Cycle 9, Day 1 (n=87, 66, 67)
- categories
- measurements
- group Id
- OG000
- spread
- 33.67
- value
- -11.6
- group Id
- OG001
- spread
- 29.54
- value
- -7.9
- group Id
- OG002
- spread
- 31.72
- value
- 2.8
- title
- Cycle 11, Day 1 (n=71, 61, 65)
- categories
- measurements
- group Id
- OG000
- spread
- 36.00
- value
- -10.2
- group Id
- OG001
- spread
- 32.87
- value
- -8.5
- group Id
- OG002
- spread
- 35.16
- value
- 1.0
- title
- Cycle 13, Day 1 (n=67, 52, 61)
- denoms
- counts
- group Id
- OG000
- value
- 168
- group Id
- OG001
- value
- 167
- group Id
- OG002
- value
- 167
- units
- Participants
- description
- The European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL Scale is scored between 0 and 100, where higher scores indicate better Global Health Status/QOL. Negative changes from baseline indicate deterioration in QOL or functioning and positive changes indicate improvement.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received bortezomib (Velcade) 1.3 mg/m\^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
- id
- OG000
- title
- Bortezomib and Dexamethasone
- description
- Participants received bortezomib 1.3 mg/m\^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
- id
- OG001
- title
- Bortezomib, Thalidomide, and Dexamethasone
- description
- Participants received bortezomib 1.3 mg/m\^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m\^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m\^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
- id
- OG002
- title
- Bortezomib, Melphalan and Prednisone
- param Type
- MEAN
- population Description
- Intent-to-treat population with available data at each time point (indicated by "n").
- reporting Status
- POSTED
- time Frame
- Baseline and Day 1 of Cycles 3, 5, 7, 9, 11 and 13
- title
- Change From Baseline in EORTC QLQ-C30 - Global Health Status
- type
- SECONDARY
- unit Of Measure
- units on a scale
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Preserved source evidence · Not medical advice