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) Emotional 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 emotional 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=115,125,128)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MPR+R | 4.8 | 25.00 | Not reported | Not reported | Not reported |
| MPR+p | 2.7 | 22.59 | Not reported | Not reported | Not reported |
| MPp+p | 6.8 | 18.75 | Not reported | Not reported | Not reported |
Cycle 7 - approximately Month 7 (n=98,111,112)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MPR+R | 8.8 | 24.94 | Not reported | Not reported | Not reported |
| MPR+p | 4.2 | 20.38 | Not reported | Not reported | Not reported |
| MPp+p | 5.0 | 21.56 | Not reported | Not reported | Not reported |
Cycle 10 - approximately Month 10 (n=86,92,97)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MPR+R | 9.0 | 23.28 | Not reported | Not reported | Not reported |
| MPR+p | 1.6 | 22.07 | Not reported | Not reported | Not reported |
| MPp+p | 4.7 | 22.05 | Not reported | Not reported | Not reported |
Cycle 13 - approximately Month 13 (n=73,73,83)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MPR+R | 8.2 | 24.59 | Not reported | Not reported | Not reported |
| MPR+p | 1.1 | 21.78 | Not reported | Not reported | Not reported |
| MPp+p | 6.6 | 21.78 | Not reported | Not reported | Not reported |
Cycle 16 - approximately Month 16 (n=63,52,63)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MPR+R | 9.9 | 23.23 | Not reported | Not reported | Not reported |
| MPR+p | -0.2 | 21.57 | Not reported | Not reported | Not reported |
| MPp+p | 6.9 | 19.72 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 25.00
- value
- 4.8
- group Id
- OG001
- spread
- 22.59
- value
- 2.7
- group Id
- OG002
- spread
- 18.75
- value
- 6.8
- title
- Cycle 4 - approximately Month 4 (n=115,125,128)
- categories
- measurements
- group Id
- OG000
- spread
- 24.94
- value
- 8.8
- group Id
- OG001
- spread
- 20.38
- value
- 4.2
- group Id
- OG002
- spread
- 21.56
- value
- 5.0
- title
- Cycle 7 - approximately Month 7 (n=98,111,112)
- categories
- measurements
- group Id
- OG000
- spread
- 23.28
- value
- 9.0
- group Id
- OG001
- spread
- 22.07
- value
- 1.6
- group Id
- OG002
- spread
- 22.05
- value
- 4.7
- title
- Cycle 10 - approximately Month 10 (n=86,92,97)
- categories
- measurements
- group Id
- OG000
- spread
- 24.59
- value
- 8.2
- group Id
- OG001
- spread
- 21.78
- value
- 1.1
- group Id
- OG002
- spread
- 21.78
- value
- 6.6
- title
- Cycle 13 - approximately Month 13 (n=73,73,83)
- categories
- measurements
- group Id
- OG000
- spread
- 23.23
- value
- 9.9
- group Id
- OG001
- spread
- 21.57
- value
- -0.2
- group Id
- OG002
- spread
- 19.72
- value
- 6.9
- title
- Cycle 16 - approximately Month 16 (n=63,52,63)
- 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 emotional 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) Emotional Functioning Scale
- type
- SECONDARY
- unit Of Measure
- units on a scale
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Preserved source evidence · Not medical advice