TriangleNCT00405756 · OUTCOME
Change From Baseline to Cycles 4, 7, 10, 13 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning 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-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of role functioning.
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=119,127,130)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MPR+R | 1.8 | 33.18 | Not reported | Not reported | Not reported |
| MPR+p | 3.0 | 30.75 | Not reported | Not reported | Not reported |
| MPp+p | 7.4 | 26.34 | Not reported | Not reported | Not reported |
Cycle 7 - approximately Month 7 (n=99,112,113)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MPR+R | 5.7 | 35.57 | Not reported | Not reported | Not reported |
| MPR+p | 8.0 | 32.42 | Not reported | Not reported | Not reported |
| MPp+p | 6.9 | 31.16 | Not reported | Not reported | Not reported |
Cycle 10 - approximately Month 10 (n=86,95,95)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MPR+R | 9.3 | 35.76 | Not reported | Not reported | Not reported |
| MPR+p | 7.5 | 36.29 | Not reported | Not reported | Not reported |
| MPp+p | 5.6 | 31.29 | Not reported | Not reported | Not reported |
Cycle 13 - approximately Month 13 (n=74,74,82)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MPR+R | 9.7 | 40.36 | Not reported | Not reported | Not reported |
| MPR+p | 11.7 | 33.42 | Not reported | Not reported | Not reported |
| MPp+p | 5.7 | 30.68 | Not reported | Not reported | Not reported |
Cycle 16 - approximately Month 16 (n=64,53,63)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MPR+R | 12.2 | 40.09 | Not reported | Not reported | Not reported |
| MPR+p | 8.5 | 34.22 | Not reported | Not reported | Not reported |
| MPp+p | 7.1 | 31.93 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 33.18
- value
- 1.8
- group Id
- OG001
- spread
- 30.75
- value
- 3.0
- group Id
- OG002
- spread
- 26.34
- value
- 7.4
- title
- Cycle 4 - approximately Month 4 (n=119,127,130)
- categories
- measurements
- group Id
- OG000
- spread
- 35.57
- value
- 5.7
- group Id
- OG001
- spread
- 32.42
- value
- 8.0
- group Id
- OG002
- spread
- 31.16
- value
- 6.9
- title
- Cycle 7 - approximately Month 7 (n=99,112,113)
- categories
- measurements
- group Id
- OG000
- spread
- 35.76
- value
- 9.3
- group Id
- OG001
- spread
- 36.29
- value
- 7.5
- group Id
- OG002
- spread
- 31.29
- value
- 5.6
- title
- Cycle 10 - approximately Month 10 (n=86,95,95)
- categories
- measurements
- group Id
- OG000
- spread
- 40.36
- value
- 9.7
- group Id
- OG001
- spread
- 33.42
- value
- 11.7
- group Id
- OG002
- spread
- 30.68
- value
- 5.7
- title
- Cycle 13 - approximately Month 13 (n=74,74,82)
- categories
- measurements
- group Id
- OG000
- spread
- 40.09
- value
- 12.2
- group Id
- OG001
- spread
- 34.22
- value
- 8.5
- group Id
- OG002
- spread
- 31.93
- value
- 7.1
- title
- Cycle 16 - approximately Month 16 (n=64,53,63)
- 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-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of role functioning.
- 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 and 16 in European Organization for Research and Treatment of Cancer Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale
- type
- SECONDARY
- unit Of Measure
- units on a scale
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Preserved source evidence · Not medical advice