TriangleNCT00405756 · OUTCOME
Kaplan Meier Estimates of Overall Survival (OS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- weeks
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- up to 177 weeks
What was measured
Data as of 11 May 2010 cutoff. Overall survival (OS) was defined as the time between randomization and death. Participants who died, regardless of the cause of death, were considered to have had an event. Participants who were lost to follow-up prior to the end of the trial, or who were withdrawn from the trial, were censored at the time of last contact. Participants who were still being treated were censored at the last available date available, or clinical cut-off date, if it was earlier.
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
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MPR+R | NA | Not reported | NA | NA | Not able to estimate since few participants died as of the May 11, 2010 cut-off. |
| MPR+p | NA | Not reported | 148.43 | NA | Not able to estimate since few participants died as of the May 11, 2010 cut-off. |
| MPp+p | NA | Not reported | NA | NA | Not able to estimate since few participants died as of the May 11, 2010 cut-off. |
Complete source fields
- classes
- categories
- measurements
- comment
- Not able to estimate since few participants died as of the May 11, 2010 cut-off.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Not able to estimate since few participants died as of the May 11, 2010 cut-off.
- group Id
- OG001
- lower Limit
- 148.43
- upper Limit
- NA
- value
- NA
- comment
- Not able to estimate since few participants died as of the May 11, 2010 cut-off.
- group Id
- OG002
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- 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. Overall survival (OS) was defined as the time between randomization and death. Participants who died, regardless of the cause of death, were considered to have had an event. Participants who were lost to follow-up prior to the end of the trial, or who were withdrawn from the trial, were censored at the time of last contact. Participants who were still being treated were censored at the last available date available, or clinical cut-off date, if it was earlier.
- dispersion Type
- 95% Confidence Interval
- 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
- MEDIAN
- population Description
- Intent to treat population
- reporting Status
- POSTED
- time Frame
- up to 177 weeks
- title
- Kaplan Meier Estimates of Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- weeks
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice