TriangleNCT01835158 · 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 5 years
What was measured
Progression free survival (PFS) was investigator assessed and is measured from the beginning of treatment until patient progression or death. Progression was determined using RECIST 1.1 criteria, progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).The primary analysis will be based on the stratified log-rank statistic to compare the two treatment arms on PFS. The Kaplan-Meier product-limit estimator will be used to estimate PFS distributions.Progression Free Survival was assessed per investigator, as this was the protocol-specified endpoint, and both investigator and independent review analyses of the PFS endpoint have been published
Analysis population: All patients that were enrolled on to study.
Groups in this outcome
Arm I (Cabozantinib-s-malate)
Patients receive 60mg cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Arm II (Sunitinib Malate)
Patients receive 50mg sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Arm I (Cabozantinib-s-malate) | 79 |
| Arm II (Sunitinib Malate) | 78 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Cabozantinib-s-malate) | 8.2 | Not reported | 6.2 | 8.8 | Not reported |
| Arm II (Sunitinib Malate) | 5.6 | Not reported | 3.4 | 8.1 | Not reported |
Source statistical analyses
- ci Lower Limit
- .46
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- .95
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.012
- param Type
- Hazard Ratio (HR)
- param Value
- 0.66
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- .46
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- .95
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.012
- param Type
- Hazard Ratio (HR)
- param Value
- 0.66
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.2
- upper Limit
- 8.8
- value
- 8.2
- group Id
- OG001
- lower Limit
- 3.4
- upper Limit
- 8.1
- value
- 5.6
- denoms
- counts
- group Id
- OG000
- value
- 79
- group Id
- OG001
- value
- 78
- units
- Participants
- description
- Progression free survival (PFS) was investigator assessed and is measured from the beginning of treatment until patient progression or death. Progression was determined using RECIST 1.1 criteria, progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).The primary analysis will be based on the stratified log-rank statistic to compare the two treatment arms on PFS. The Kaplan-Meier product-limit estimator will be used to estimate PFS distributions.Progression Free Survival was assessed per investigator, as this was the protocol-specified endpoint, and both investigator and independent review analyses of the PFS endpoint have been published
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive 60mg cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Arm I (Cabozantinib-s-malate)
- description
- Patients receive 50mg sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Arm II (Sunitinib Malate)
- param Type
- MEDIAN
- population Description
- All patients that were enrolled on to study.
- reporting Status
- POSTED
- time Frame
- Up to 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