TriangleNCT03783442 · OUTCOME
Progression-Free Survival (PFS)
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
Progression-free survival is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, and an absolute increase of at least 5 mm, or unequivocal progression of existing nontarget lesions, or the appearance of 1 or more new lesions. 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
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 | 326 |
| Placebo + Chemotherapy | 323 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tislelizumab + Chemotherapy | 7.3 | Not reported | 6.9 | 8.3 | Not reported |
| Placebo + Chemotherapy | 5.6 | Not reported | 4.9 | 6.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.52
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.75
- 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
- <0.0001
- 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
- 0.52
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.75
- 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
- <0.0001
- 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
- 6.9
- upper Limit
- 8.3
- value
- 7.3
- group Id
- OG001
- lower Limit
- 4.9
- upper Limit
- 6.0
- value
- 5.6
- denoms
- counts
- group Id
- OG000
- value
- 326
- group Id
- OG001
- value
- 323
- units
- Participants
- description
- Progression-free survival is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, and an absolute increase of at least 5 mm, or unequivocal progression of existing nontarget lesions, or the appearance of 1 or more new lesions. 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
- 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
- Progression-Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice