TriangleNCT03777657 · OUTCOME
Overall Survival in the Intent-to-Treat (ITT) Analysis Set
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
- From randomization up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months.
What was measured
Overall survival (OS) is defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method.
Analysis population: The Intent-to-Treat (ITT) Analysis Set included all randomized participants.
Groups in this outcome
Tislelizumab + Chemotherapy
Participants received 200 mg of tislelizumab intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with 200 mg tislelizumab, with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.
Placebo + Chemotherapy
Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Tislelizumab + Chemotherapy | 501 |
| Placebo + Chemotherapy | 496 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tislelizumab + Chemotherapy | 15.0 | Not reported | 13.6 | 16.5 | Not reported |
| Placebo + Chemotherapy | 12.9 | Not reported | 12.1 | 14.1 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.70
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.92
- estimate Comment
- The stratified hazard ratio and two-sided 95% confidence interval were estimated using a Cox proportional hazard regression model, including treatment arm as a covariate, and region, PD-L1 expression, and presence of peritoneal metastasis as strata.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0011
- p Value Comment
- The one sided P value boundary for superiority of overall survival in all randomized participants at final analysis was 0.0226 based on 776 actual observed deaths.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.80
- statistical Comment
- One-Sided Log-Rank test stratified by region (Asia vs Europe/North America), PD-L1 expression (\<5% vs ≥5%), and presence of peritoneal metastasis.
- statistical Method
- One-Sided Log-Rank Test
Complete source fields
- analyses
- ci Lower Limit
- 0.70
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.92
- estimate Comment
- The stratified hazard ratio and two-sided 95% confidence interval were estimated using a Cox proportional hazard regression model, including treatment arm as a covariate, and region, PD-L1 expression, and presence of peritoneal metastasis as strata.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0011
- p Value Comment
- The one sided P value boundary for superiority of overall survival in all randomized participants at final analysis was 0.0226 based on 776 actual observed deaths.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.80
- statistical Comment
- One-Sided Log-Rank test stratified by region (Asia vs Europe/North America), PD-L1 expression (\<5% vs ≥5%), and presence of peritoneal metastasis.
- statistical Method
- One-Sided Log-Rank Test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 13.6
- upper Limit
- 16.5
- value
- 15.0
- group Id
- OG001
- lower Limit
- 12.1
- upper Limit
- 14.1
- value
- 12.9
- denoms
- counts
- group Id
- OG000
- value
- 501
- group Id
- OG001
- value
- 496
- units
- Participants
- description
- Overall survival (OS) is defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 200 mg of tislelizumab intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with 200 mg tislelizumab, with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.
- id
- OG000
- title
- Tislelizumab + Chemotherapy
- description
- Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.
- id
- OG001
- title
- Placebo + Chemotherapy
- param Type
- MEDIAN
- population Description
- The Intent-to-Treat (ITT) Analysis Set included all randomized participants.
- reporting Status
- POSTED
- time Frame
- From randomization up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months.
- title
- Overall Survival in the Intent-to-Treat (ITT) Analysis Set
- type
- PRIMARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice