TriangleNCT02579863 · OUTCOME
Overall Survival (OS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to approximately 55 months
What was measured
OS was defined as the time from randomization to death due to any cause. OS was calculated from the product-limit (Kaplan-Meier) method for censored data. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. This is an event-driven (events of death) outcome measure. At the time of data cut-off, there were an insufficient number of events from the censored data to be able to estimate certain parameters (e.g. medians). The database cutoff date was August 3, 2020.
Analysis population: The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.
Groups in this outcome
Pembrolizumab + Lenalidomide + Dexamethasone
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
Lenolidomide + Dexamethasone
Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
| Group | Source count |
|---|---|
| Pembrolizumab + Lenalidomide + Dexamethasone | 156 |
| Lenolidomide + Dexamethasone | 154 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab + Lenalidomide + Dexamethasone | NA | Not reported | 44.6 | NA | The Median was not reached, and the Upper Limit could not be estimated due to insufficient number of events before the date of data cutoff. |
| Lenolidomide + Dexamethasone | NA | Not reported | NA | NA | The Median was not reached, and the Upper and Lower Limits could not be estimated due to insufficient number of events before the date of data cutoff. |
Source statistical analyses
- ci Lower Limit
- 0.81
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.84
- estimate Comment
- Based on Cox regression model with treatment as a covariate stratified by "Age" (\<75 years vs \>= 75 years) and "ISS stage" (I or II vs. III).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.83416
- param Type
- Hazard Ratio (HR)
- param Value
- 1.22
- statistical Method
- Stratified log-rank test
Complete source fields
- analyses
- ci Lower Limit
- 0.81
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.84
- estimate Comment
- Based on Cox regression model with treatment as a covariate stratified by "Age" (\<75 years vs \>= 75 years) and "ISS stage" (I or II vs. III).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.83416
- param Type
- Hazard Ratio (HR)
- param Value
- 1.22
- statistical Method
- Stratified log-rank test
- classes
- categories
- measurements
- comment
- The Median was not reached, and the Upper Limit could not be estimated due to insufficient number of events before the date of data cutoff.
- group Id
- OG000
- lower Limit
- 44.6
- upper Limit
- NA
- value
- NA
- comment
- The Median was not reached, and the Upper and Lower Limits could not be estimated due to insufficient number of events before the date of data cutoff.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 156
- group Id
- OG001
- value
- 154
- units
- Participants
- description
- OS was defined as the time from randomization to death due to any cause. OS was calculated from the product-limit (Kaplan-Meier) method for censored data. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. This is an event-driven (events of death) outcome measure. At the time of data cut-off, there were an insufficient number of events from the censored data to be able to estimate certain parameters (e.g. medians). The database cutoff date was August 3, 2020.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
- id
- OG000
- title
- Pembrolizumab + Lenalidomide + Dexamethasone
- description
- Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
- id
- OG001
- title
- Lenolidomide + Dexamethasone
- param Type
- MEDIAN
- population Description
- The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.
- reporting Status
- POSTED
- time Frame
- Up to approximately 55 months
- title
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice