TriangleNCT00911859 · OUTCOME
Overall Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Days
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the date of randomization till the date of death, as assessed up to the end of study (approximately 3 years)
What was measured
Overall survival is defined as the time interval in days between the date of randomization and the participant's death from any cause.
Analysis population: Intent-to-treat (ITT) population: all randomized participants.
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) | 54 |
| Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab | 52 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: VMP (Velcade+Melphalan+Prednisone) | NA | Not reported | NA | NA | Insufficient number of participants with events; therefore, median and 95% CI not reached. |
| Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab | NA | Not reported | 783 | NA | Insufficient number of participants with events; therefore, median and upper limit of 95% CI not reached. |
Complete source fields
- classes
- categories
- measurements
- comment
- Insufficient number of participants with events; therefore, median and 95% CI not reached.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Insufficient number of participants with events; therefore, median and upper limit of 95% CI not reached.
- group Id
- OG001
- lower Limit
- 783
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 54
- group Id
- OG001
- value
- 52
- units
- Participants
- description
- Overall survival is defined as the time interval in days between the date of randomization and the participant's death from any cause.
- dispersion Type
- 95% Confidence Interval
- 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
- MEDIAN
- population Description
- Intent-to-treat (ITT) population: all randomized participants.
- reporting Status
- POSTED
- time Frame
- From the date of randomization till the date of death, as assessed up to the end of study (approximately 3 years)
- title
- Overall Survival
- type
- SECONDARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice