TriangleNCT00424047 · OUTCOME
Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale (Later Cut-off Date of 02 March 2008)
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
- Randomization to cut off date of 02 March 2008; up to 51 months
What was measured
The time to first worsening of the ECOG performance status was calculated as the time from randomization to the date of the first worsening compared with the last ECOG evaluation obtained prior to randomization. Data were censored at the last date that the participant was known to be unchanged or improved from before randomization for the participants who had not had worsened at the time of the analysis and for the patients who were lost to follow-up before worsening in the ECOG performance status was documented.
Analysis population: Intent to Treat includes all participants who were randomized to study drug; six ECOG scores were missing at the March 2008 cut-off.
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. Pulse dexamethasone 40 mg 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 40 mg PO QD for Days 1-4 every 28 days. Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned. After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression.
| Group | Source count |
|---|---|
| Lenalidomide Plus Dexamethasone | 173 |
| Placebo Plus Dexamethasone | 172 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenalidomide Plus Dexamethasone | 10.1 | Not reported | 8.1 | 16.1 | Not reported |
| Placebo Plus Dexamethasone | 12.3 | Not reported | 10.1 | 24.1 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.866
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.486
- estimate Comment
- Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.359
- p Value Comment
- The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.
- param Type
- Hazard Ratio (HR)
- param Value
- 1.135
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.866
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.486
- estimate Comment
- Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (CC-5013/Dex:Placebo/Dex)
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.359
- p Value Comment
- The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups.
- param Type
- Hazard Ratio (HR)
- param Value
- 1.135
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.1
- upper Limit
- 16.1
- value
- 10.1
- group Id
- OG001
- lower Limit
- 10.1
- upper Limit
- 24.1
- value
- 12.3
- denoms
- counts
- group Id
- OG000
- value
- 173
- group Id
- OG001
- value
- 172
- units
- Participants
- description
- The time to first worsening of the ECOG performance status was calculated as the time from randomization to the date of the first worsening compared with the last ECOG evaluation obtained prior to randomization. Data were censored at the last date that the participant was known to be unchanged or improved from before randomization for the participants who had not had worsened at the time of the analysis and for the patients who were lost to follow-up before worsening in the ECOG performance status was documented.
- 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. Pulse dexamethasone 40 mg 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 40 mg PO QD for Days 1-4 every 28 days. Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned. After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression.
- id
- OG001
- title
- Placebo Plus Dexamethasone
- param Type
- MEDIAN
- population Description
- Intent to Treat includes all participants who were randomized to study drug; six ECOG scores were missing at the March 2008 cut-off.
- reporting Status
- POSTED
- time Frame
- Randomization to cut off date of 02 March 2008; up to 51 months
- title
- Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale (Later Cut-off Date of 02 March 2008)
- type
- SECONDARY
- unit Of Measure
- weeks
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Preserved source evidence · Not medical advice