TriangleNCT03777657 · OUTCOME
Overall Survival in PD-L1 Positive Participants
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 primary analysis data cut-off date of 8 October 2021; Median (range) time on follow-up was 11.8 (0.1 - 33.4) 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 PD-L1-Positive Analysis Set included all randomized participants whose tumors were PD-L1 positive (defined as PD-L1 TAP score ≥ 5%)
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 | 274 |
| Placebo + Chemotherapy | 272 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tislelizumab + Chemotherapy | 17.2 | Not reported | 13.9 | 21.3 | Not reported |
| Placebo + Chemotherapy | 12.6 | Not reported | 12.0 | 14.4 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.59
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.94
- 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 and presence of peritoneal metastasis as strata.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0056
- p Value Comment
- The superiority boundary at the primary overall survival analysis was predefined using the O'Brien-Fleming boundary approximated using the Hwang-Shih-DeCani spending function at 0.0092.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.74
- statistical Comment
- One-Sided Log-Rank Test stratified by regions (Asia versus Europe/North America) and presence of peritoneal metastasis (yes vs no).
- statistical Method
- One-sided Log Rank Test
Complete source fields
- analyses
- ci Lower Limit
- 0.59
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.94
- 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 and presence of peritoneal metastasis as strata.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0056
- p Value Comment
- The superiority boundary at the primary overall survival analysis was predefined using the O'Brien-Fleming boundary approximated using the Hwang-Shih-DeCani spending function at 0.0092.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.74
- statistical Comment
- One-Sided Log-Rank Test stratified by regions (Asia versus Europe/North America) and presence of peritoneal metastasis (yes vs no).
- statistical Method
- One-sided Log Rank Test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 13.9
- upper Limit
- 21.3
- value
- 17.2
- group Id
- OG001
- lower Limit
- 12.0
- upper Limit
- 14.4
- value
- 12.6
- denoms
- counts
- group Id
- OG000
- value
- 274
- group Id
- OG001
- value
- 272
- 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 PD-L1-Positive Analysis Set included all randomized participants whose tumors were PD-L1 positive (defined as PD-L1 TAP score ≥ 5%)
- reporting Status
- POSTED
- time Frame
- From randomization up to the primary analysis data cut-off date of 8 October 2021; Median (range) time on follow-up was 11.8 (0.1 - 33.4) months.
- title
- Overall Survival in PD-L1 Positive Participants
- type
- PRIMARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice