TriangleNCT00911859 · OUTCOME
Change From Baseline to Cycle 9 in Global Health Status/Quality of Life Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Scores on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline (Day 1 predose) and Cycle 9 (Week 54)
What was measured
Global health status/quality of life is a subscale of the EORTC QOL C30, which comprises two questions related to overall health/quality of life during the past week. The raw score to each question ranged from 1 (very poor) to 7 (excellent). The raw mean score of health status/quality of life subscale is calculated for each participant and a linear transformation applied to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") health and quality of life.
Analysis population: Intent-to-treat (ITT) population: all randomized participants with evaluable data during baseline and Cycle 9
Groups in this outcome
Part 2: VMP (Velcade+Melphalan+Prednisone)
Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab
Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
| Group | Source count |
|---|---|
| Part 2: VMP (Velcade+Melphalan+Prednisone) | 31 |
| Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab | 25 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: VMP (Velcade+Melphalan+Prednisone) | 14.78 | 25.250 | Not reported | Not reported | Not reported |
| Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab | 8.33 | 31.088 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 25.250
- value
- 14.78
- group Id
- OG001
- spread
- 31.088
- value
- 8.33
- denoms
- counts
- group Id
- OG000
- value
- 31
- group Id
- OG001
- value
- 25
- units
- Participants
- description
- Global health status/quality of life is a subscale of the EORTC QOL C30, which comprises two questions related to overall health/quality of life during the past week. The raw score to each question ranged from 1 (very poor) to 7 (excellent). The raw mean score of health status/quality of life subscale is calculated for each participant and a linear transformation applied to standardize the raw score, so that scores range from 0 to 100; a higher score represents a higher ("better") health and quality of life.
- dispersion Type
- Standard Deviation
- groups
- description
- Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
- id
- OG000
- title
- Part 2: VMP (Velcade+Melphalan+Prednisone)
- description
- Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
- id
- OG001
- title
- Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab
- param Type
- MEAN
- population Description
- Intent-to-treat (ITT) population: all randomized participants with evaluable data during baseline and Cycle 9
- reporting Status
- POSTED
- time Frame
- Baseline (Day 1 predose) and Cycle 9 (Week 54)
- title
- Change From Baseline to Cycle 9 in Global Health Status/Quality of Life Subscale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30)
- type
- SECONDARY
- unit Of Measure
- Scores on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice