TriangleNCT03783442 · OUTCOME
Objective Response Rate (ORR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Response was assessed every 6 weeks for the first 48 weeks, then every 9 weeks thereafter; up to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months.
What was measured
ORR is defined as the percentage of participants whose best overall response (BOR) was complete response (CR) or partial response (PR) assessed by the investigator per RECIST v1.1. Tumor assessments included computed tomography (CT) scans or magnetic resonance imaging (MRI), with preference for CT, of the neck, chest, and abdomen. CR: Disappearance of all target and nontarget lesions with no new lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm. PR: Disappearance of all target lesions with persistence of 1 or more nontarget lesion(s), no new lesions, and/or maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Testing for all secondary efficacy endpoints was conducted at the time of the primary analysis (data cutoff date of 28 February 2022).
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 | 63.5 | Not reported | 58.0 | 68.7 | Not reported |
| Placebo + Chemotherapy | 42.4 | Not reported | 37.0 | 48.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.73
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.27
- estimate Comment
- Odds ratio was calculated using the Cochran-Mantel-Haenszel method, stratified by pooled geographic region, prior definitive therapy, and Investigator choice of chemotherapy.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Odds Ratio (OR)
- param Value
- 2.38
- statistical Comment
- Two-sided Cochran-Mantel-Haenszel test was stratified by pooled geographic region, prior definitive therapy, and Investigator choice of chemotherapy.
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 1.73
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.27
- estimate Comment
- Odds ratio was calculated using the Cochran-Mantel-Haenszel method, stratified by pooled geographic region, prior definitive therapy, and Investigator choice of chemotherapy.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Odds Ratio (OR)
- param Value
- 2.38
- statistical Comment
- Two-sided Cochran-Mantel-Haenszel test was stratified by pooled geographic region, prior definitive therapy, and Investigator choice of chemotherapy.
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 58.0
- upper Limit
- 68.7
- value
- 63.5
- group Id
- OG001
- lower Limit
- 37.0
- upper Limit
- 48.0
- value
- 42.4
- denoms
- counts
- group Id
- OG000
- value
- 326
- group Id
- OG001
- value
- 323
- units
- Participants
- description
- ORR is defined as the percentage of participants whose best overall response (BOR) was complete response (CR) or partial response (PR) assessed by the investigator per RECIST v1.1. Tumor assessments included computed tomography (CT) scans or magnetic resonance imaging (MRI), with preference for CT, of the neck, chest, and abdomen. CR: Disappearance of all target and nontarget lesions with no new lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm. PR: Disappearance of all target lesions with persistence of 1 or more nontarget lesion(s), no new lesions, and/or maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Testing for all secondary efficacy endpoints was conducted at the time of the primary analysis (data cutoff date of 28 February 2022).
- 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
- NUMBER
- population Description
- ITT Analysis Set
- reporting Status
- POSTED
- time Frame
- Response was assessed every 6 weeks for the first 48 weeks, then every 9 weeks thereafter; up to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months.
- title
- Objective Response Rate (ORR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice