TriangleNCT01865747 · OUTCOME
Progression-free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- PFS is measured from the date of randomization until the date of first documented disease progression or date of death from any cause as determined by the Independent Radiology Committee (IRC) per RECIST 1.1, assessed for up to 17 months.
What was measured
The primary analysis of PFS is the time from randomization to date of first documented tumor progression as determined by investigator (per RECIST 1.1 criteria) or death due to any cause, whichever occurred first. A Kaplan-Meier analysis was performed to estimate the median duration.
Analysis population: The pre-specified primary analysis of PFS was based on the first 375 randomized subjects (187 cabozantinib and 188 everolimus).
Groups in this outcome
Cabozantinib (XL184)
Cabozantinib (XL184) 60 mg tablet once daily. Cabozantinib tablets
Everolimus (Afinitor)
Everolimus (Afinitor) 10 mg tablet once daily. Everolimus (Afinitor) tablets
| Group | Source count |
|---|---|
| Cabozantinib (XL184) | 187 |
| Everolimus (Afinitor) | 188 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cabozantinib (XL184) | 7.4 | Not reported | 5.6 | 9.1 | Not reported |
| Everolimus (Afinitor) | 3.8 | Not reported | 3.7 | 5.4 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.45
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.74
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.58
- statistical Comment
- The Log-Rank Test was stratified by the Memorial Sloan-Kettering Cancer Center (MSKCC) group and number of prior VEGFR TKIs.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.45
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.74
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.58
- statistical Comment
- The Log-Rank Test was stratified by the Memorial Sloan-Kettering Cancer Center (MSKCC) group and number of prior VEGFR TKIs.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.6
- upper Limit
- 9.1
- value
- 7.4
- group Id
- OG001
- lower Limit
- 3.7
- upper Limit
- 5.4
- value
- 3.8
- denoms
- counts
- group Id
- OG000
- value
- 187
- group Id
- OG001
- value
- 188
- units
- Participants
- description
- The primary analysis of PFS is the time from randomization to date of first documented tumor progression as determined by investigator (per RECIST 1.1 criteria) or death due to any cause, whichever occurred first. 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
- Everolimus (Afinitor) 10 mg tablet once daily. Everolimus (Afinitor) tablets
- id
- OG001
- title
- Everolimus (Afinitor)
- param Type
- NUMBER
- population Description
- The pre-specified primary analysis of PFS was based on the first 375 randomized subjects (187 cabozantinib and 188 everolimus).
- reporting Status
- POSTED
- time Frame
- PFS is measured from the date of randomization until the date of first documented disease progression or date of death from any cause as determined by the Independent Radiology Committee (IRC) per RECIST 1.1, assessed for up to 17 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