TriangleNCT01844505 · 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 randomization to date of death (Assessed up to September 2016, approximately 39 months)
What was measured
OS was defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
Analysis population: All randomized participants
Groups in this outcome
Nivolumab
Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
Nivolumab + Ipilimumab
Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
Ipilimumab
Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
| Group | Source count |
|---|---|
| Nivolumab | 316 |
| Nivolumab + Ipilimumab | 314 |
| Ipilimumab | 315 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab | NA | Not reported | 29.08 | NA | Median OS was not reached |
| Nivolumab + Ipilimumab | NA | Not reported | NA | NA | Median OS was not reached |
| Ipilimumab | 19.98 | Not reported | 17.08 | 24.61 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.50
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 98
- ci Upper Limit
- 0.78
- estimate Comment
- Stratified Cox proportional hazard model. Ratio of Nivolumab over Ipilimumab
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.63
- statistical Comment
- Log-rank Test stratified by PD-L1 status, BRAF status, and M stage at screening as entered into the Interactive Voice Response System (IVRS).
- statistical Method
- Log Rank
- ci Lower Limit
- 0.42
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 98
- ci Upper Limit
- 0.72
- estimate Comment
- Stratified Cox proportional hazard model. Ratio of Nivolumab+Ipilimumab over Ipilimumab.
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.55
- statistical Comment
- Log-rank Test stratified by PD-L1 status, BRAF status, and M stage at screening as entered into the IVRS.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.50
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 98
- ci Upper Limit
- 0.78
- estimate Comment
- Stratified Cox proportional hazard model. Ratio of Nivolumab over Ipilimumab
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.63
- statistical Comment
- Log-rank Test stratified by PD-L1 status, BRAF status, and M stage at screening as entered into the Interactive Voice Response System (IVRS).
- statistical Method
- Log Rank
- ci Lower Limit
- 0.42
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 98
- ci Upper Limit
- 0.72
- estimate Comment
- Stratified Cox proportional hazard model. Ratio of Nivolumab+Ipilimumab over Ipilimumab.
- group Ids
- OG001
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.55
- statistical Comment
- Log-rank Test stratified by PD-L1 status, BRAF status, and M stage at screening as entered into the IVRS.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Median OS was not reached
- group Id
- OG000
- lower Limit
- 29.08
- upper Limit
- NA
- value
- NA
- comment
- Median OS was not reached
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG002
- lower Limit
- 17.08
- upper Limit
- 24.61
- value
- 19.98
- denoms
- counts
- group Id
- OG000
- value
- 316
- group Id
- OG001
- value
- 314
- group Id
- OG002
- value
- 315
- units
- Participants
- description
- OS was defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
- id
- OG000
- title
- Nivolumab
- description
- Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
- id
- OG001
- title
- Nivolumab + Ipilimumab
- description
- Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
- id
- OG002
- title
- Ipilimumab
- param Type
- MEDIAN
- population Description
- All randomized participants
- reporting Status
- POSTED
- time Frame
- From randomization to date of death (Assessed up to September 2016, approximately 39 months)
- title
- Overall Survival (OS)
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice