TriangleNCT01642004 · OUTCOME
Overall Survival (OS) Time in Months for All Randomized Participants 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 199 deaths, up to November 2014, approximately 25 months
What was measured
OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. 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. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the actual analysis occurring at 199 deaths.
Analysis population: All randomized participants
Groups in this outcome
Nivolumab
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
Docetaxel
Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
| Group | Source count |
|---|---|
| Nivolumab | 135 |
| Docetaxel | 137 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab | 9.23 | Not reported | 7.33 | 13.27 | Not reported |
| Docetaxel | 6.01 | Not reported | 5.13 | 7.33 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.43
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 96.85
- ci Upper Limit
- 0.81
- estimate Comment
- Stratified Cox proportional hazard model. HR = Nivolumab over Docetaxel
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0002
- p Value Comment
- Stratified by region (US/Canada, Rest Of World (ROW), Europe) and prior treatment regimen (Paclitaxel, Another agent) as entered in the Interactive Voice Response System (IVRS).
- param Type
- Hazard Ratio (HR)
- param Value
- 0.59
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.43
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 96.85
- ci Upper Limit
- 0.81
- estimate Comment
- Stratified Cox proportional hazard model. HR = Nivolumab over Docetaxel
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0002
- p Value Comment
- Stratified by region (US/Canada, Rest Of World (ROW), Europe) and prior treatment regimen (Paclitaxel, Another agent) as entered in the Interactive Voice Response System (IVRS).
- param Type
- Hazard Ratio (HR)
- param Value
- 0.59
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.33
- upper Limit
- 13.27
- value
- 9.23
- group Id
- OG001
- lower Limit
- 5.13
- upper Limit
- 7.33
- value
- 6.01
- denoms
- counts
- group Id
- OG000
- value
- 135
- group Id
- OG001
- value
- 137
- units
- Participants
- description
- OS was defined as the time between the date of randomization and the date of death from any cause. Participants were censored at the date they were last known to be alive. Median OS time was calculated using Kaplan-Meier (KM) method. 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. Interim analysis (Primary Endpoint) was planned to occur after at least 196 deaths, with the actual analysis occurring at 199 deaths.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
- id
- OG000
- title
- Nivolumab
- description
- Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
- id
- OG001
- title
- Docetaxel
- param Type
- MEDIAN
- population Description
- All randomized participants
- reporting Status
- POSTED
- time Frame
- Randomization until 199 deaths, up to November 2014, approximately 25 months
- title
- Overall Survival (OS) Time in Months for All Randomized Participants at Primary Endpoint
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice