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) Diarrhoea 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 for a symptom scale like the diarrhea scale = higher level of symptomatology/problems.
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=115,125,124)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MPR+R | 2.3 | 28.85 | Not reported | Not reported | Not reported |
| MPR+p | 1.9 | 24.06 | Not reported | Not reported | Not reported |
| MPp+p | 3.2 | 25.65 | Not reported | Not reported | Not reported |
Cycle 7 - approximately Month 7 (n=98,109,112)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MPR+R | 3.4 | 25.54 | Not reported | Not reported | Not reported |
| MPR+p | -1.2 | 23.09 | Not reported | Not reported | Not reported |
| MPp+p | 0.9 | 22.13 | Not reported | Not reported | Not reported |
Cycle 10 - approximately Month 10 (n=87,92,95)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MPR+R | 1.1 | 22.98 | Not reported | Not reported | Not reported |
| MPR+p | 1.4 | 20.91 | Not reported | Not reported | Not reported |
| MPp+p | -0.0 | 21.19 | Not reported | Not reported | Not reported |
Cycle 13 - approximately Month 13 (n=73,73,80)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MPR+R | 5.5 | 30.43 | Not reported | Not reported | Not reported |
| MPR+p | -1.4 | 18.78 | Not reported | Not reported | Not reported |
| MPp+p | 0.8 | 18.35 | Not reported | Not reported | Not reported |
Cycle 16 - approximately Month 16 (n=63,52,61)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MPR+R | 10.6 | 35.83 | Not reported | Not reported | Not reported |
| MPR+p | 1.3 | 19.75 | Not reported | Not reported | Not reported |
| MPp+p | 0.5 | 17.74 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 28.85
- value
- 2.3
- group Id
- OG001
- spread
- 24.06
- value
- 1.9
- group Id
- OG002
- spread
- 25.65
- value
- 3.2
- title
- Cycle 4 - approximately Month 4 (n=115,125,124)
- categories
- measurements
- group Id
- OG000
- spread
- 25.54
- value
- 3.4
- group Id
- OG001
- spread
- 23.09
- value
- -1.2
- group Id
- OG002
- spread
- 22.13
- value
- 0.9
- title
- Cycle 7 - approximately Month 7 (n=98,109,112)
- categories
- measurements
- group Id
- OG000
- spread
- 22.98
- value
- 1.1
- group Id
- OG001
- spread
- 20.91
- value
- 1.4
- group Id
- OG002
- spread
- 21.19
- value
- -0.0
- title
- Cycle 10 - approximately Month 10 (n=87,92,95)
- categories
- measurements
- group Id
- OG000
- spread
- 30.43
- value
- 5.5
- group Id
- OG001
- spread
- 18.78
- value
- -1.4
- group Id
- OG002
- spread
- 18.35
- value
- 0.8
- title
- Cycle 13 - approximately Month 13 (n=73,73,80)
- categories
- measurements
- group Id
- OG000
- spread
- 35.83
- value
- 10.6
- group Id
- OG001
- spread
- 19.75
- value
- 1.3
- group Id
- OG002
- spread
- 17.74
- value
- 0.5
- title
- Cycle 16 - approximately Month 16 (n=63,52,61)
- 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 for a symptom scale like the diarrhea scale = higher level of symptomatology/problems.
- 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) Diarrhoea Scale
- type
- SECONDARY
- unit Of Measure
- units on a scale
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Preserved source evidence · Not medical advice