TriangleNCT03142334 · OUTCOME
Disease-free Survival (DFS) as Assessed by the Investigator
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
- Up to approximately 42 months (database cutoff date 14 Dec 2020)
What was measured
DFS, as assessed by the investigator, is defined as the time from randomization to the first documented local recurrence, distant kidney cancer metastasis(es), or death due to any cause, whichever occurs first. Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastasis status (M0 versus M1 no evidence of disease (NED) by investigator) and Eastern Cooperative Oncology Group Performance Status (ECOG PS) (0 versus 1), United States (US) participant (Yes versus No) within M0 group by investigator was used to report hazard ratio (HR) and 95% confidence intervals (CIs).
Analysis population: All randomized participants
Groups in this outcome
Pembrolizumab
Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).
Placebo
Participants received placebo (saline solution) via IV infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).
| Group | Source count |
|---|---|
| Pembrolizumab | 496 |
| Placebo | 498 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab | NA | Not reported | NA | NA | NA = Median, lower and upper limit of 95% CIs for DFS was not reportable at the time of last disease assessment due to insufficient number of participants with events by the time of the data cutoff (14-Dec-2020). |
| Placebo | NA | Not reported | NA | NA | NA = Median, lower and upper limit of 95% CIs for DFS was not reportable at the time of last disease assessment due to insufficient number of participants with events by the time of the data cutoff (14-Dec-2020). |
Source statistical analyses
- ci Lower Limit
- 0.53
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.87
- estimate Comment
- Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastasis status, ECOG PS, and US participant within M0 group by investigator was used to calculate HR and 95% CIs.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- HR and the associated 95% CIs were calculated based on Cox Regression model and p-value was calculated based on log-rank test, in accordance with the statistical analysis plan.
- non Inferiority Type
- OTHER
- p Value
- 0.0010
- param Type
- Hazard Ratio (HR)
- param Value
- 0.68
- statistical Comment
- One-sided p-value was based on log-rank test stratified by metastasis status, ECOG PS, US participant within M0 group by investigator.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.53
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.87
- estimate Comment
- Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastasis status, ECOG PS, and US participant within M0 group by investigator was used to calculate HR and 95% CIs.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- HR and the associated 95% CIs were calculated based on Cox Regression model and p-value was calculated based on log-rank test, in accordance with the statistical analysis plan.
- non Inferiority Type
- OTHER
- p Value
- 0.0010
- param Type
- Hazard Ratio (HR)
- param Value
- 0.68
- statistical Comment
- One-sided p-value was based on log-rank test stratified by metastasis status, ECOG PS, US participant within M0 group by investigator.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- NA = Median, lower and upper limit of 95% CIs for DFS was not reportable at the time of last disease assessment due to insufficient number of participants with events by the time of the data cutoff (14-Dec-2020).
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- NA = Median, lower and upper limit of 95% CIs for DFS was not reportable at the time of last disease assessment due to insufficient number of participants with events by the time of the data cutoff (14-Dec-2020).
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 496
- group Id
- OG001
- value
- 498
- units
- Participants
- description
- DFS, as assessed by the investigator, is defined as the time from randomization to the first documented local recurrence, distant kidney cancer metastasis(es), or death due to any cause, whichever occurs first. Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by metastasis status (M0 versus M1 no evidence of disease (NED) by investigator) and Eastern Cooperative Oncology Group Performance Status (ECOG PS) (0 versus 1), United States (US) participant (Yes versus No) within M0 group by investigator was used to report hazard ratio (HR) and 95% confidence intervals (CIs).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).
- id
- OG000
- title
- Pembrolizumab
- description
- Participants received placebo (saline solution) via IV infusion on Day 1 of each 3-week cycle for up to 17 cycles (up to approximately 1 year).
- id
- OG001
- title
- Placebo
- param Type
- MEDIAN
- population Description
- All randomized participants
- reporting Status
- POSTED
- time Frame
- Up to approximately 42 months (database cutoff date 14 Dec 2020)
- title
- Disease-free Survival (DFS) as Assessed by the Investigator
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice