TriangleNCT01668784 · OUTCOME
Investigator-assessed Time of 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 up to disease progression or death (approximately up to 105 Months)
What was measured
PFS=time from randomization to date of first documented tumor progression as determined by investigator (per RECIST 1.1 criteria or clinical) or death due to any cause, whichever occurred first. Participants who die without a reported prior progression and without subsequent anti-cancer therapy 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 the date they were randomized. Participants who received any subsequent anti-cancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to or on initiation date of the subsequent anti-cancer therapy. Progressive disease: \>=20% increase in sum of target lesion diameters and sum must show absolute increase of \>=5mm; smallest sum on study as reference. Based on Kaplan-Meier Estimates.
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 | 4.21 | Not reported | 3.68 | 5.36 | Not reported |
| Everolimus | 4.50 | Not reported | 3.71 | 5.52 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.72
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.99
- estimate Comment
- Stratified Cox proportional hazard model. Hazard ratio is nivolumab over everolimus.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0340
- param Type
- Hazard Ratio (HR)
- param Value
- 0.84
- statistical Comment
- Log-rank Test stratified by the Memorial Sloan-Kettering Cancer Center (MSKCC) risk group, number of prior anti-angiogenic therapies, and the region.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.72
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.99
- estimate Comment
- Stratified Cox proportional hazard model. Hazard ratio is nivolumab over everolimus.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0340
- param Type
- Hazard Ratio (HR)
- param Value
- 0.84
- statistical Comment
- Log-rank Test stratified by the Memorial Sloan-Kettering Cancer Center (MSKCC) risk group, number of prior anti-angiogenic therapies, and the region.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.68
- upper Limit
- 5.36
- value
- 4.21
- group Id
- OG001
- lower Limit
- 3.71
- upper Limit
- 5.52
- value
- 4.50
- denoms
- counts
- group Id
- OG000
- value
- 410
- group Id
- OG001
- value
- 411
- units
- Participants
- description
- PFS=time from randomization to date of first documented tumor progression as determined by investigator (per RECIST 1.1 criteria or clinical) or death due to any cause, whichever occurred first. Participants who die without a reported prior progression and without subsequent anti-cancer therapy 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 the date they were randomized. Participants who received any subsequent anti-cancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to or on initiation date of the subsequent anti-cancer therapy. Progressive disease: \>=20% increase in sum of target lesion diameters and sum must show absolute increase of \>=5mm; smallest sum on study as reference. Based on Kaplan-Meier Estimates.
- 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
- from randomization up to disease progression or death (approximately up to 105 Months)
- title
- Investigator-assessed Time of Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice