TriangleNCT03675737 · OUTCOME
Overall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
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 45.9 months
What was measured
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. OS was estimated using the product-limit (Kaplan-Meier) method for censored data.
Analysis population: The analysis population included randomized participants with a PD-L1 CPS of ≥10.
Groups in this outcome
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen). Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
Placebo + Chemotherapy (FP or CAPOX Regimen)
Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
| Group | Source count |
|---|---|
| Pembrolizumab + Chemotherapy (FP or CAPOX Regimen) | 279 |
| Placebo + Chemotherapy (FP or CAPOX Regimen) | 272 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab + Chemotherapy (FP or CAPOX Regimen) | 15.7 | Not reported | 13.8 | 19.3 | Not reported |
| Placebo + Chemotherapy (FP or CAPOX Regimen) | 11.8 | Not reported | 10.3 | 12.7 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.53
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.79
- estimate Comment
- Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region and chemotherapy regimen with small strata collapsed.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- One-sided p-value based on log-rank test stratified by geographic region and chemotherapy regimen with small strata collapsed.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.65
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.53
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.79
- estimate Comment
- Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region and chemotherapy regimen with small strata collapsed.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- p Value Comment
- One-sided p-value based on log-rank test stratified by geographic region and chemotherapy regimen with small strata collapsed.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.65
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 13.8
- upper Limit
- 19.3
- value
- 15.7
- group Id
- OG001
- lower Limit
- 10.3
- upper Limit
- 12.7
- value
- 11.8
- denoms
- counts
- group Id
- OG000
- value
- 279
- group Id
- OG001
- value
- 272
- units
- Participants
- description
- OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. OS was estimated using the product-limit (Kaplan-Meier) method for censored data.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen). Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
- id
- OG000
- title
- Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)
- description
- Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
- id
- OG001
- title
- Placebo + Chemotherapy (FP or CAPOX Regimen)
- param Type
- MEDIAN
- population Description
- The analysis population included randomized participants with a PD-L1 CPS of ≥10.
- reporting Status
- POSTED
- time Frame
- Up to 45.9 months
- title
- Overall Survival (OS) In Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice