TriangleNCT00405756 · OUTCOME
Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Future Perspective Scale
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 (Day 0), Months 4, 7, 10, 13, 16
What was measured
Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future.
Analysis population: Intent to treat population
Groups in this outcome
MPR+R
Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
MPR+p
Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
MPp+p
Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
| Group | Source count |
|---|---|
| MPR+R | 152 |
| MPR+p | 153 |
| MPp+p | 154 |
Reported measurements
Cycle 4 - approximately Month 4 (n=112,121,124)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MPR+R | 4.7 | 23.74 | Not reported | Not reported | Not reported |
| MPR+p | 4.3 | 23.56 | Not reported | Not reported | Not reported |
| MPp+p | 7.6 | 22.38 | Not reported | Not reported | Not reported |
Cycle 7 - approximately Month 7 (n=93,108,112)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MPR+R | 14.6 | 24.45 | Not reported | Not reported | Not reported |
| MPR+p | 7.7 | 23.86 | Not reported | Not reported | Not reported |
| MPp+p | 9.8 | 20.62 | Not reported | Not reported | Not reported |
Cycle 10 - approximately Month 10 (n=83,88,97)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MPR+R | 17.3 | 27.84 | Not reported | Not reported | Not reported |
| MPR+p | 6.6 | 22.40 | Not reported | Not reported | Not reported |
| MPp+p | 14.5 | 21.73 | Not reported | Not reported | Not reported |
Cycle 13 - approximately Month 13 (n=71,73,81)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MPR+R | 17.3 | 27.15 | Not reported | Not reported | Not reported |
| MPR+p | 6.3 | 23.78 | Not reported | Not reported | Not reported |
| MPp+p | 11.9 | 24.67 | Not reported | Not reported | Not reported |
Cycle 16 - approximately Month 16 (n=62,52,62)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MPR+R | 18.5 | 25.30 | Not reported | Not reported | Not reported |
| MPR+p | 7.7 | 28.49 | Not reported | Not reported | Not reported |
| MPp+p | 14.4 | 26.62 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 23.74
- value
- 4.7
- group Id
- OG001
- spread
- 23.56
- value
- 4.3
- group Id
- OG002
- spread
- 22.38
- value
- 7.6
- title
- Cycle 4 - approximately Month 4 (n=112,121,124)
- categories
- measurements
- group Id
- OG000
- spread
- 24.45
- value
- 14.6
- group Id
- OG001
- spread
- 23.86
- value
- 7.7
- group Id
- OG002
- spread
- 20.62
- value
- 9.8
- title
- Cycle 7 - approximately Month 7 (n=93,108,112)
- categories
- measurements
- group Id
- OG000
- spread
- 27.84
- value
- 17.3
- group Id
- OG001
- spread
- 22.40
- value
- 6.6
- group Id
- OG002
- spread
- 21.73
- value
- 14.5
- title
- Cycle 10 - approximately Month 10 (n=83,88,97)
- categories
- measurements
- group Id
- OG000
- spread
- 27.15
- value
- 17.3
- group Id
- OG001
- spread
- 23.78
- value
- 6.3
- group Id
- OG002
- spread
- 24.67
- value
- 11.9
- title
- Cycle 13 - approximately Month 13 (n=71,73,81)
- categories
- measurements
- group Id
- OG000
- spread
- 25.30
- value
- 18.5
- group Id
- OG001
- spread
- 28.49
- value
- 7.7
- group Id
- OG002
- spread
- 26.62
- value
- 14.4
- title
- Cycle 16 - approximately Month 16 (n=62,52,62)
- denoms
- counts
- group Id
- OG000
- value
- 152
- group Id
- OG001
- value
- 153
- group Id
- OG002
- value
- 154
- units
- Participants
- description
- Data as of 11 May 2010 cutoff. EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future.
- dispersion Type
- Standard Deviation
- groups
- description
- Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
- id
- OG000
- title
- MPR+R
- description
- Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
- id
- OG001
- title
- MPR+p
- description
- Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
- id
- OG002
- title
- MPp+p
- param Type
- MEAN
- population Description
- Intent to treat population
- reporting Status
- POSTED
- time Frame
- Baseline (Day 0), Months 4, 7, 10, 13, 16
- title
- Change From Baseline to Cycles 4, 7, 10, 13, 16 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) In Future Perspective Scale
- type
- SECONDARY
- unit Of Measure
- units on a scale
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Preserved source evidence · Not medical advice