TriangleNCT01908426 · 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
- Up to 45 months
What was measured
Duration of PFS is defined as the time of randomization to the earlier of the following events, progressive disease as determined by Investigator (per RECIST 1.0, which is defined by a ≥ 20% increase in the sum of the longest diameter of target lesions from baseline) or death due to any cause. A Kaplan- Meier analysis was performed to estimate the median duration.
Analysis population: The prespecified primary analysis of PFS was based on the first 707 randomized subjects (470 cabozantinib, 237 placebo).
Groups in this outcome
Cabozantinib (XL184)
Cabozantinib (XL184) 60 mg tablet once daily Cabozantinib tablets
Placebo
Oral cabozantinib-matched placebo tablet once daily Placebo tablets
| Group | Source count |
|---|---|
| Cabozantinib (XL184) | 470 |
| Placebo | 237 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cabozantinib (XL184) | 5.2 | Not reported | 4.0 | 5.5 | Not reported |
| Placebo | 1.9 | Not reported | 1.9 | 1.9 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.36
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.52
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.44
- statistical Comment
- The Log Rank Test was stratified by etiology of disease, geographic region, presence of extrahepatic spread of disease and/or macrovascular invasion.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.36
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.52
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.44
- statistical Comment
- The Log Rank Test was stratified by etiology of disease, geographic region, presence of extrahepatic spread of disease and/or macrovascular invasion.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.0
- upper Limit
- 5.5
- value
- 5.2
- group Id
- OG001
- lower Limit
- 1.9
- upper Limit
- 1.9
- value
- 1.9
- denoms
- counts
- group Id
- OG000
- value
- 470
- group Id
- OG001
- value
- 237
- units
- Participants
- description
- Duration of PFS is defined as the time of randomization to the earlier of the following events, progressive disease as determined by Investigator (per RECIST 1.0, which is defined by a ≥ 20% increase in the sum of the longest diameter of target lesions from baseline) or death due to any cause. A Kaplan- Meier analysis was performed to estimate the median duration.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Cabozantinib (XL184) 60 mg tablet once daily Cabozantinib tablets
- id
- OG000
- title
- Cabozantinib (XL184)
- description
- Oral cabozantinib-matched placebo tablet once daily Placebo tablets
- id
- OG001
- title
- Placebo
- param Type
- MEDIAN
- population Description
- The prespecified primary analysis of PFS was based on the first 707 randomized subjects (470 cabozantinib, 237 placebo).
- reporting Status
- POSTED
- time Frame
- Up to 45 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