NCT01953692 · OUTCOME
Overall Survival (OS) in Participants Pooled From Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide) Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
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 78.5 months
What was measured
OS was defined as the time from first dose of study treatment to death due to any cause. OS was calculated from 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.
Analysis population: All participants pooled from the Cohort 5 (pembrolizumab + 20 or 25 mg doses of lenalidomide) with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation. The analysis was pre-specified to be a pooled analysis of all participants grouped by disease cohort (DLBCL) and treatment combination (irrespective of dose); therefore data by individual dose were not analyzed.
Groups in this outcome
Pooled Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide)
Participants from the pooled Cohort 5 received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 20 mg or 25 mg PO QD for 21 consecutive days with 7 days off within 28-day cycles.
| Group | Source count |
|---|---|
| Pooled Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide) | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pooled Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide) | 23.0 | Not reported | 6.1 | NA | NA=OS upper limit not reached at time of data cut-off due to insufficient number of participants with an event. |
Complete source fields
- classes
- categories
- measurements
- comment
- NA=OS upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
- group Id
- OG000
- lower Limit
- 6.1
- upper Limit
- NA
- value
- 23.0
- denoms
- counts
- group Id
- OG000
- value
- 18
- units
- Participants
- description
- OS was defined as the time from first dose of study treatment to death due to any cause. OS was calculated from 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.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants from the pooled Cohort 5 received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 20 mg or 25 mg PO QD for 21 consecutive days with 7 days off within 28-day cycles.
- id
- OG000
- title
- Pooled Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide)
- param Type
- MEDIAN
- population Description
- All participants pooled from the Cohort 5 (pembrolizumab + 20 or 25 mg doses of lenalidomide) with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation. The analysis was pre-specified to be a pooled analysis of all participants grouped by disease cohort (DLBCL) and treatment combination (irrespective of dose); therefore data by individual dose were not analyzed.
- reporting Status
- POSTED
- time Frame
- Up to approximately 78.5 months
- title
- Overall Survival (OS) in Participants Pooled From Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide) Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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