TriangleNCT00424047 · OUTCOME
Kaplan-Meier Estimate of Duration of Response
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 data cut off of 03 August 2005; up to 24 months
What was measured
Duration of response was calculated for responders and defined as the time from the first observation of a response (e.g., the first time that the appropriate decrease in M-protein level was observed for confirmed responders) to the first documented progression or relapse. Response duration was censored at the last adequate assessment showing evidence of no progression.
Analysis population: Intent to Treat population includes all participants who were randomized to study drug.
Groups in this outcome
Lenalidomide Plus Dexamethasone
Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle. Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.
Placebo Plus Dexamethasone
Placebo PO daily on Days 1 to 28 of each 28 day cycle. Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.
| Group | Source count |
|---|---|
| Lenalidomide Plus Dexamethasone | 104 |
| Placebo Plus Dexamethasone | 41 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenalidomide Plus Dexamethasone | 67.6 | Not reported | 42.1 | NA | NA: Data not considered materialized or estimable at this time point |
| Placebo Plus Dexamethasone | 33.3 | Not reported | 22.1 | 51.6 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.338
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.921
- estimate Comment
- Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (lenalidomide/dexamethasone : placebo/dexamethasone).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.021
- param Type
- Hazard Ratio (HR)
- param Value
- 0.558
- statistical Comment
- The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.338
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.921
- estimate Comment
- Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (lenalidomide/dexamethasone : placebo/dexamethasone).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.021
- param Type
- Hazard Ratio (HR)
- param Value
- 0.558
- statistical Comment
- The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- NA: Data not considered materialized or estimable at this time point
- group Id
- OG000
- lower Limit
- 42.1
- upper Limit
- NA
- value
- 67.6
- group Id
- OG001
- lower Limit
- 22.1
- upper Limit
- 51.6
- value
- 33.3
- denoms
- counts
- group Id
- OG000
- value
- 104
- group Id
- OG001
- value
- 41
- units
- Participants
- description
- Duration of response was calculated for responders and defined as the time from the first observation of a response (e.g., the first time that the appropriate decrease in M-protein level was observed for confirmed responders) to the first documented progression or relapse. Response duration was censored at the last adequate assessment showing evidence of no progression.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle. Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.
- id
- OG000
- title
- Lenalidomide Plus Dexamethasone
- description
- Placebo PO daily on Days 1 to 28 of each 28 day cycle. Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.
- id
- OG001
- title
- Placebo Plus Dexamethasone
- param Type
- MEDIAN
- population Description
- Intent to Treat population includes all participants who were randomized to study drug.
- reporting Status
- POSTED
- time Frame
- Up to data cut off of 03 August 2005; up to 24 months
- title
- Kaplan-Meier Estimate of Duration of Response
- type
- POST_HOC
- unit Of Measure
- weeks
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Preserved source evidence · Not medical advice