TriangleNCT02546986 · OUTCOME
Kaplan Meier Estimate of Overall Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- From Day 1 of treatment up to the clinical cut-off date of 12 April 2017, whichever occurred earlier; median follow-up time for OS was 11.3 months in the CC-486 + PBZ arm and 12.2 months in the PBZ + Placebo arm
What was measured
Overall survival (OS) was defined as the time in months between day 1 of treatment and death from any cause. Participants who were still alive as of the clinical cut-off date had their OS censored at the date of last contact or clinical cut-off, whichever was earlier. Participants who were lost to follow-up prior to the end of the study or who were withdrawn from the study were censored at the time of last contact.
Analysis population: The Intent-to-Treat population includes all participants who were randomized.
Groups in this outcome
CC-486 and Pembrolizumab (CC-486 + PBZ)
Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
Placebo and Pembrolizumab (PBO + PBZ)
Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
| Group | Source count |
|---|---|
| CC-486 and Pembrolizumab (CC-486 + PBZ) | 51 |
| Placebo and Pembrolizumab (PBO + PBZ) | 49 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CC-486 and Pembrolizumab (CC-486 + PBZ) | 11.9 | Not reported | 7.2 | NA | The upper limit was not estimable as participants were still alive at the time of the clinical cut-off date |
| Placebo and Pembrolizumab (PBO + PBZ) | NA | Not reported | 11.0 | NA | Not estimable as participants were still alive at the time of the clinical cut-off date. |
Source statistical analyses
- ci Lower Limit
- 0.830
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 2.276
- estimate Comment
- Hazard ratio and associated 2-sided 90% CIs were estimated using Cox proportional hazard model.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2968
- param Type
- Hazard Ratio (HR)
- param Value
- 1.375
- statistical Comment
- Stratified by squamous cell carcinoma vs non-squamous cell carcinoma).
- statistical Method
- Stratified Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.830
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 2.276
- estimate Comment
- Hazard ratio and associated 2-sided 90% CIs were estimated using Cox proportional hazard model.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2968
- param Type
- Hazard Ratio (HR)
- param Value
- 1.375
- statistical Comment
- Stratified by squamous cell carcinoma vs non-squamous cell carcinoma).
- statistical Method
- Stratified Log Rank
- classes
- categories
- measurements
- comment
- The upper limit was not estimable as participants were still alive at the time of the clinical cut-off date
- group Id
- OG000
- lower Limit
- 7.2
- upper Limit
- NA
- value
- 11.9
- comment
- Not estimable as participants were still alive at the time of the clinical cut-off date.
- group Id
- OG001
- lower Limit
- 11.0
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 51
- group Id
- OG001
- value
- 49
- units
- Participants
- description
- Overall survival (OS) was defined as the time in months between day 1 of treatment and death from any cause. Participants who were still alive as of the clinical cut-off date had their OS censored at the date of last contact or clinical cut-off, whichever was earlier. Participants who were lost to follow-up prior to the end of the study or who were withdrawn from the study were censored at the time of last contact.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Participants received CC-486 300 mg tablets by mouth (PO) on Days 1-14 of each 21-day treatment cycle and pembrolizumab (PBZ) 200 mg administered as a 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle until radiologic disease progression (DP), unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
- id
- OG000
- title
- CC-486 and Pembrolizumab (CC-486 + PBZ)
- description
- Participant received placebo tablets (identically matching in appearance to CC-486) administered orally daily on Days 1-14 plus pembrolizumab 200 mg administered as a 30-minute IV infusion on Day 1 of each 21-day cycle until radiologic disease progression, unacceptable toxicity, initiation of a new anticancer therapy, withdrawal of consent, subject refusal, physician decision, or death.
- id
- OG001
- title
- Placebo and Pembrolizumab (PBO + PBZ)
- param Type
- MEDIAN
- population Description
- The Intent-to-Treat population includes all participants who were randomized.
- reporting Status
- POSTED
- time Frame
- From Day 1 of treatment up to the clinical cut-off date of 12 April 2017, whichever occurred earlier; median follow-up time for OS was 11.3 months in the CC-486 + PBZ arm and 12.2 months in the PBZ + Placebo arm
- title
- Kaplan Meier Estimate of Overall Survival
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice