TriangleNCT01844505 · OUTCOME
Progression Free Survival (PFS)
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 until disease progression or death, whichever occurred first (assessed up to February 2015, approximately 20 months)
What was measured
PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the Investigator, or death due to any cause, whichever occurred first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. Participants treated beyond progression were considered to have progressive disease at the time of the initial progression event regardless of subsequent tumor response. Particpants who started anti-cancer therapy without a prior reported progression were censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.
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 | 6.87 | Not reported | 4.34 | 9.46 | Not reported |
| Nivolumab + Ipilimumab | 11.50 | Not reported | 8.90 | 16.72 | Not reported |
| Ipilimumab | 2.89 | Not reported | 2.79 | 3.42 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.43
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 99.5
- ci Upper Limit
- 0.76
- estimate Comment
- Stratified Cox proportional hazard model. Ratio of Nivolumab over Ipimlimumab.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.57
- statistical Method
- Stratified Log Rank test
- ci Lower Limit
- 0.31
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 99.5
- ci Upper Limit
- 0.57
- 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
- 0.42
- statistical Method
- Stratified Log Rank test
Complete source fields
- analyses
- ci Lower Limit
- 0.43
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 99.5
- ci Upper Limit
- 0.76
- estimate Comment
- Stratified Cox proportional hazard model. Ratio of Nivolumab over Ipimlimumab.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.57
- statistical Method
- Stratified Log Rank test
- ci Lower Limit
- 0.31
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 99.5
- ci Upper Limit
- 0.57
- 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
- 0.42
- statistical Method
- Stratified Log Rank test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.34
- upper Limit
- 9.46
- value
- 6.87
- group Id
- OG001
- lower Limit
- 8.90
- upper Limit
- 16.72
- value
- 11.50
- group Id
- OG002
- lower Limit
- 2.79
- upper Limit
- 3.42
- value
- 2.89
- denoms
- counts
- group Id
- OG000
- value
- 316
- group Id
- OG001
- value
- 314
- group Id
- OG002
- value
- 315
- units
- Participants
- description
- PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the Investigator, or death due to any cause, whichever occurred first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die were censored on their date of randomization. Participants treated beyond progression were considered to have progressive disease at the time of the initial progression event regardless of subsequent tumor response. Particpants who started anti-cancer therapy without a prior reported progression were censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.
- 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 until disease progression or death, whichever occurred first (assessed up to February 2015, approximately 20 months)
- title
- Progression Free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice