TriangleNCT02576509 · 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
- time from the date of randomization to the date of the first objectively documented tumor progression or death, assessed up to May 2019 (approximately 40 months)
What was measured
PFS is defined as the time from the date of randomization to the date of the first objectively documented tumor progression as assessed by BICR according to RECIST 1.1 or death due to any cause in all randomized participants. Participants who die without a reported prior progression and without initiation of subsequent anti-cancer therapy will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last tumor assessment. Participants who did not have baseline tumor assessment will be censored on the date they were randomized. Participants who did not have any on study tumor assessments and did not die will be censored on the date they were randomized. Participants who started any subsequent anti-cancer therapy without a prior reported progression will be censored at the last tumor assessment prior to subsequent anti-cancer therapy.
Analysis population: all randomized participants
Groups in this outcome
Nivolumab 240 mg
Nivolumab 240 mg intravenously (IV) every 2 weeks until disease progression or unacceptable toxicity
Sorafenib 400 mg
Sorafenib 400 mg orally (PO) twice a day (BID) until disease progression or unacceptable toxicity
| Group | Source count |
|---|---|
| Nivolumab 240 mg | 371 |
| Sorafenib 400 mg | 372 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab 240 mg | 3.68 | Not reported | 3.06 | 3.88 | Not reported |
| Sorafenib 400 mg | 3.75 | Not reported | 3.71 | 4.47 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.79
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.10
- estimate Comment
- Nivolumab over Sorafenib; Stratified Cox proportional hazard model
- group Ids
- OG000
- OG001
- non Inferiority Comment
- no test was performed due to OS p-value result above the prior threshold
- non Inferiority Type
- OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 0.93
Complete source fields
- analyses
- ci Lower Limit
- 0.79
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.10
- estimate Comment
- Nivolumab over Sorafenib; Stratified Cox proportional hazard model
- group Ids
- OG000
- OG001
- non Inferiority Comment
- no test was performed due to OS p-value result above the prior threshold
- non Inferiority Type
- OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 0.93
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.06
- upper Limit
- 3.88
- value
- 3.68
- group Id
- OG001
- lower Limit
- 3.71
- upper Limit
- 4.47
- value
- 3.75
- denoms
- counts
- group Id
- OG000
- value
- 371
- group Id
- OG001
- value
- 372
- units
- Participants
- description
- PFS is defined as the time from the date of randomization to the date of the first objectively documented tumor progression as assessed by BICR according to RECIST 1.1 or death due to any cause in all randomized participants. Participants who die without a reported prior progression and without initiation of subsequent anti-cancer therapy will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last tumor assessment. Participants who did not have baseline tumor assessment will be censored on the date they were randomized. Participants who did not have any on study tumor assessments and did not die will be censored on the date they were randomized. Participants who started any subsequent anti-cancer therapy without a prior reported progression will be censored at the last tumor assessment prior to subsequent anti-cancer therapy.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab 240 mg intravenously (IV) every 2 weeks until disease progression or unacceptable toxicity
- id
- OG000
- title
- Nivolumab 240 mg
- description
- Sorafenib 400 mg orally (PO) twice a day (BID) until disease progression or unacceptable toxicity
- id
- OG001
- title
- Sorafenib 400 mg
- param Type
- MEDIAN
- population Description
- all randomized participants
- reporting Status
- POSTED
- time Frame
- time from the date of randomization to the date of the first objectively documented tumor progression or death, assessed up to May 2019 (approximately 40 months)
- title
- Progression-Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice