TriangleNCT01729338 · OUTCOME
QLQ-C30 Question 30
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, 3 months, 5 months
What was measured
Measured as mean quality of life in study subjects, quantitatively scored using the standardized and validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ). Question 30: How would you rate your overall quality of life during the past week? 7 point scores are standardized to a scale of 0-100, where 100 means highest possible quality.
Analysis population: Participants who completed questionnaire.
Groups in this outcome
Velcade, Cyclophosphamide, Revlimid
INDUCTION (28-day cycles for 8 cycles): * VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15 * Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15 * Dexamethasone 40 mg PO days 1,8 and 15 MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death): * Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21 * Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15 Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles \[10,12,14, etc.\]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until
| Group | Source count |
|---|---|
| Velcade, Cyclophosphamide, Revlimid | 10 |
Reported measurements
Baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Velcade, Cyclophosphamide, Revlimid | 51.7 | 24.1 | Not reported | Not reported | Not reported |
3 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Velcade, Cyclophosphamide, Revlimid | 66.7 | 19.7 | Not reported | Not reported | Not reported |
5 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Velcade, Cyclophosphamide, Revlimid | 66.7 | 12.9 | Not reported | Not reported | Not reported |
Source statistical analyses
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.1
- p Value Comment
- baseline, 3 month
- statistical Method
- paired t-test
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.09
- statistical Comment
- baseline, month 5
- statistical Method
- paired t-test
Complete source fields
- analyses
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.1
- p Value Comment
- baseline, 3 month
- statistical Method
- paired t-test
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.09
- statistical Comment
- baseline, month 5
- statistical Method
- paired t-test
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 24.1
- value
- 51.7
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 19.7
- value
- 66.7
- title
- 3 months
- categories
- measurements
- group Id
- OG000
- spread
- 12.9
- value
- 66.7
- title
- 5 months
- denoms
- counts
- group Id
- OG000
- value
- 10
- units
- Participants
- description
- Measured as mean quality of life in study subjects, quantitatively scored using the standardized and validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ). Question 30: How would you rate your overall quality of life during the past week? 7 point scores are standardized to a scale of 0-100, where 100 means highest possible quality.
- dispersion Type
- Standard Deviation
- groups
- description
- INDUCTION (28-day cycles for 8 cycles): * VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15 * Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15 * Dexamethasone 40 mg PO days 1,8 and 15 MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death): * Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21 * Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15 Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles \[10,12,14, etc.\]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until
- id
- OG000
- title
- Velcade, Cyclophosphamide, Revlimid
- param Type
- MEAN
- population Description
- Participants who completed questionnaire.
- reporting Status
- POSTED
- time Frame
- baseline, 3 months, 5 months
- title
- QLQ-C30 Question 30
- type
- SECONDARY
- unit Of Measure
- units on a scale
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Preserved source evidence · Not medical advice