TriangleNCT01668784 · OUTCOME
Overall Survival (OS) at Primary Endpoint
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
- Randomization until 398 deaths, up to May 2015 (approximately 30 months)
What was measured
Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Interim analysis for the Primary Endpoint occurred after 398 deaths (70% of the total OS events needed for final analysis). At that time the data monitoring committee noted that the pre-specified boundary for OS (nominal significance level p \< 0.0148) was crossed while no new safety signals that would affect continuation of the study were found. The study was stopped early by the Sponsor, Bristol-Myers Squibb (BMS) and the interim analysis became the final analysis. As a result, participants in the everolimus groups could be assessed for a crossover to nivolumab treatment if they met all inclusion criteria.
Analysis population: All randomized participants; any participants that was randomized to any treatment group in the study.
Groups in this outcome
Nivolumab
Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
Everolimus
Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
| Group | Source count |
|---|---|
| Nivolumab | 410 |
| Everolimus | 411 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab | 25.00 | Not reported | 21.75 | NA | N.A.: Not Available: Too few events to estimate the upper limit of the confidence interval |
| Everolimus | 19.55 | Not reported | 17.64 | 23.06 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.57
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 98.52
- ci Upper Limit
- 0.93
- estimate Comment
- Stratified Cox proportional hazard model. Hazard ratio (HR) was Nivolumab over Everolimus.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0018
- p Value Comment
- The boundary for statistical significance required the p-value to be less than 0.0148 at the interim analyses.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.73
- statistical Comment
- Log-rank Test stratified by the Memorial Sloan-Kettering Cancer Center risk group, number of prior anti-angiogenic therapies, and the region.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.57
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 98.52
- ci Upper Limit
- 0.93
- estimate Comment
- Stratified Cox proportional hazard model. Hazard ratio (HR) was Nivolumab over Everolimus.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0018
- p Value Comment
- The boundary for statistical significance required the p-value to be less than 0.0148 at the interim analyses.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.73
- statistical Comment
- Log-rank Test stratified by the Memorial Sloan-Kettering Cancer Center risk group, number of prior anti-angiogenic therapies, and the region.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- N.A.: Not Available: Too few events to estimate the upper limit of the confidence interval
- group Id
- OG000
- lower Limit
- 21.75
- upper Limit
- NA
- value
- 25.00
- group Id
- OG001
- lower Limit
- 17.64
- upper Limit
- 23.06
- value
- 19.55
- denoms
- counts
- group Id
- OG000
- value
- 410
- group Id
- OG001
- value
- 411
- units
- Participants
- description
- Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Interim analysis for the Primary Endpoint occurred after 398 deaths (70% of the total OS events needed for final analysis). At that time the data monitoring committee noted that the pre-specified boundary for OS (nominal significance level p \< 0.0148) was crossed while no new safety signals that would affect continuation of the study were found. The study was stopped early by the Sponsor, Bristol-Myers Squibb (BMS) and the interim analysis became the final analysis. As a result, participants in the everolimus groups could be assessed for a crossover to nivolumab treatment if they met all inclusion criteria.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
- id
- OG000
- title
- Nivolumab
- description
- Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
- id
- OG001
- title
- Everolimus
- param Type
- MEDIAN
- population Description
- All randomized participants; any participants that was randomized to any treatment group in the study.
- reporting Status
- POSTED
- time Frame
- Randomization until 398 deaths, up to May 2015 (approximately 30 months)
- title
- Overall Survival (OS) at Primary Endpoint
- type
- PRIMARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice