TriangleNCT03783442 · OUTCOME
Overall Survival (OS) in Participants With a PD-L1 Score ≥ 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
- From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months.
What was measured
OS is defined as the time from the date of randomization until the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method. Primary analysis (data cut-off date of 28 February 2022) was the pre-defined analysis at which the primary endpoint was tested for superiority. Testing for all secondary efficacy endpoints was conducted at the time of the primary analysis.
Analysis population: ITT Analysis Set participants with PD-L1 score ≥ 10%
Groups in this outcome
Tislelizumab + Chemotherapy
Participants received tislelizumab 200 mg administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.
Placebo + Chemotherapy
Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.
| Group | Source count |
|---|---|
| Tislelizumab + Chemotherapy | 116 |
| Placebo + Chemotherapy | 107 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tislelizumab + Chemotherapy | 16.6 | Not reported | 15.3 | 24.4 | Not reported |
| Placebo + Chemotherapy | 10.0 | Not reported | 8.6 | 13.3 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.44
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.87
- estimate Comment
- Stratified Hazard ratio was based on Cox regression model including treatment arm as a covariate and stratified by pooled geographic region (Asia vs. Rest of World), prior definitive therapy and Investigator choice of chemotherapy as strata.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0029
- param Type
- Stratified Hazard Ratio
- param Value
- 0.62
- statistical Comment
- One-sided p-value estimated from log rank test stratified by pooled geographic region, prior definitive therapy and Investigator chemotherapy choice.
- statistical Method
- Stratified Log-rank test
Complete source fields
- analyses
- ci Lower Limit
- 0.44
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.87
- estimate Comment
- Stratified Hazard ratio was based on Cox regression model including treatment arm as a covariate and stratified by pooled geographic region (Asia vs. Rest of World), prior definitive therapy and Investigator choice of chemotherapy as strata.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0029
- param Type
- Stratified Hazard Ratio
- param Value
- 0.62
- statistical Comment
- One-sided p-value estimated from log rank test stratified by pooled geographic region, prior definitive therapy and Investigator chemotherapy choice.
- statistical Method
- Stratified Log-rank test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 15.3
- upper Limit
- 24.4
- value
- 16.6
- group Id
- OG001
- lower Limit
- 8.6
- upper Limit
- 13.3
- value
- 10.0
- denoms
- counts
- group Id
- OG000
- value
- 116
- group Id
- OG001
- value
- 107
- units
- Participants
- description
- OS is defined as the time from the date of randomization until the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method. Primary analysis (data cut-off date of 28 February 2022) was the pre-defined analysis at which the primary endpoint was tested for superiority. Testing for all secondary efficacy endpoints was conducted at the time of the primary analysis.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received tislelizumab 200 mg administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.
- id
- OG000
- title
- Tislelizumab + Chemotherapy
- description
- Participants received placebo administered IV on Day 1 of each 3-week treatment cycle together with an investigator-chosen chemotherapy doublet until unacceptable toxicity, disease progression or withdrawal for other reasons.
- id
- OG001
- title
- Placebo + Chemotherapy
- param Type
- MEDIAN
- population Description
- ITT Analysis Set participants with PD-L1 score ≥ 10%
- reporting Status
- POSTED
- time Frame
- From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months.
- title
- Overall Survival (OS) in Participants With a PD-L1 Score ≥ 10%
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice