TriangleNCT02627963 · 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 date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Disease progression was assessed every 8 weeks (up to approximately 5 years)
What was measured
The PFS, as assessed by a blinded independent radiological review (IRR), is defined as the time from randomization to first documentation of objective tumor progression (progressive disease) or death due to any reasons whichever comes first. Disease progression per RECIST 1.1 criteria is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Analysis population: Intent-to-treat (ITT) Population included all randomized participants.
Groups in this outcome
Tivozanib Hydrochloride
Participants randomized to this arm received the study drug, tivozanib hydrochloride.
Sorafenib
Participants randomized to this arm received the comparator drug, sorafenib.
| Group | Source count |
|---|---|
| Tivozanib Hydrochloride | 175 |
| Sorafenib | 175 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Tivozanib Hydrochloride | 5.59 | Not reported | 5.29 | 7.33 | Not reported |
| Sorafenib | 3.88 | Not reported | 3.71 | 5.55 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.56
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.94
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0165
- p Value Comment
- A one-sided, log-rank test stratified for IMDC risk category and prior therapy (two VEGFR TKIs vs. a checkpoint inhibitor plus a VEGFR TKI vs. a VEGFR TKI plus any other systemic agent) at a significance level of α = 0.025 was used.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.73
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.56
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.94
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0165
- p Value Comment
- A one-sided, log-rank test stratified for IMDC risk category and prior therapy (two VEGFR TKIs vs. a checkpoint inhibitor plus a VEGFR TKI vs. a VEGFR TKI plus any other systemic agent) at a significance level of α = 0.025 was used.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.73
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.29
- upper Limit
- 7.33
- value
- 5.59
- group Id
- OG001
- lower Limit
- 3.71
- upper Limit
- 5.55
- value
- 3.88
- denoms
- counts
- group Id
- OG000
- value
- 175
- group Id
- OG001
- value
- 175
- units
- Participants
- description
- The PFS, as assessed by a blinded independent radiological review (IRR), is defined as the time from randomization to first documentation of objective tumor progression (progressive disease) or death due to any reasons whichever comes first. Disease progression per RECIST 1.1 criteria is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants randomized to this arm received the study drug, tivozanib hydrochloride.
- id
- OG000
- title
- Tivozanib Hydrochloride
- description
- Participants randomized to this arm received the comparator drug, sorafenib.
- id
- OG001
- title
- Sorafenib
- param Type
- MEDIAN
- population Description
- Intent-to-treat (ITT) Population included all randomized participants.
- reporting Status
- POSTED
- time Frame
- From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Disease progression was assessed every 8 weeks (up to approximately 5 years)
- 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