TriangleNCT02105636 · OUTCOME
Overall Survival (OS)
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 date of randomization to date of death (Up to approximately 18 months)
What was measured
OS was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Median OS time was calculated using Kaplan-Meier (KM) method.
Analysis population: All randomized participants
Groups in this outcome
Nivolumab 3mg/kg
Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
Investigators Choice
Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligrams per square meter (mg/m\^2) for the first dose followed that a doses of 250 mg/m\^2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m\^2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m\^2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice
| Group | Source count |
|---|---|
| Nivolumab 3mg/kg | 240 |
| Investigators Choice | 121 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab 3mg/kg | 7.49 | Not reported | 5.49 | 9.10 | Not reported |
| Investigators Choice | 5.06 | Not reported | 4.04 | 6.05 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.53
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.92
- estimate Comment
- Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm.
- group Description
- Stratified Cox proportional hazard model. HR = Nivolumab over investigator's choice therapy (Cetuximab, Methotrexate, or Docetaxel)
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0101
- p Value Comment
- Log-rank Test stratified by prior treatment with cetuximab (yes, no) as entered into the Interactive Voice Response System (IVRS). For OS the boundary for statistical significance requires the p-value to be less than 0.0227.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.70
- 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
- 0.92
- estimate Comment
- Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm.
- group Description
- Stratified Cox proportional hazard model. HR = Nivolumab over investigator's choice therapy (Cetuximab, Methotrexate, or Docetaxel)
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0101
- p Value Comment
- Log-rank Test stratified by prior treatment with cetuximab (yes, no) as entered into the Interactive Voice Response System (IVRS). For OS the boundary for statistical significance requires the p-value to be less than 0.0227.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.70
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.49
- upper Limit
- 9.10
- value
- 7.49
- group Id
- OG001
- lower Limit
- 4.04
- upper Limit
- 6.05
- value
- 5.06
- denoms
- counts
- group Id
- OG000
- value
- 240
- group Id
- OG001
- value
- 121
- units
- Participants
- description
- OS was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Median OS time was calculated using Kaplan-Meier (KM) method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
- id
- OG000
- title
- Nivolumab 3mg/kg
- description
- Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligrams per square meter (mg/m\^2) for the first dose followed that a doses of 250 mg/m\^2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m\^2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m\^2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice
- id
- OG001
- title
- Investigators Choice
- param Type
- MEDIAN
- population Description
- All randomized participants
- reporting Status
- POSTED
- time Frame
- From date of randomization to date of death (Up to approximately 18 months)
- title
- Overall Survival (OS)
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice