TriangleNCT02601209 · OUTCOME
Progression-free Survival (PFS) (Phase II Analysis Group 2 - Initial Treatment Period)
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 2 years
What was measured
Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and an upper confidence boundary from a 1-sided, 85% confidence interval are estimated using the Kaplan-Meier methods.
Analysis population: Phase II Analysis Group 2 - Initial Treatment Period
Groups in this outcome
Phase II - Analysis Group 2 MLN0128
Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.
Phase II - Analysis Group 2 Pazopanib
Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.
| Group | Source count |
|---|---|
| Phase II - Analysis Group 2 MLN0128 | 56 |
| Phase II - Analysis Group 2 Pazopanib | 58 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase II - Analysis Group 2 MLN0128 | 2.0 | Not reported | 1.9 | 3.0 | Not reported |
| Phase II - Analysis Group 2 Pazopanib | 2.1 | Not reported | 1.9 | 3.7 | Not reported |
Source statistical analyses
- ci Num Sides
- ONE_SIDED
- ci Pct Value
- 85
- ci Upper Limit
- 1.70
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1419
- param Type
- Hazard Ratio (HR)
- param Value
- 1.36
- statistical Comment
- 1-sided statistical test and p-value
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Num Sides
- ONE_SIDED
- ci Pct Value
- 85
- ci Upper Limit
- 1.70
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1419
- param Type
- Hazard Ratio (HR)
- param Value
- 1.36
- statistical Comment
- 1-sided statistical test and p-value
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.9
- upper Limit
- 3.0
- value
- 2.0
- group Id
- OG001
- lower Limit
- 1.9
- upper Limit
- 3.7
- value
- 2.1
- denoms
- counts
- group Id
- OG000
- value
- 56
- group Id
- OG001
- value
- 58
- units
- Participants
- description
- Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and an upper confidence boundary from a 1-sided, 85% confidence interval are estimated using the Kaplan-Meier methods.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.
- id
- OG000
- title
- Phase II - Analysis Group 2 MLN0128
- description
- Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.
- id
- OG001
- title
- Phase II - Analysis Group 2 Pazopanib
- param Type
- MEDIAN
- population Description
- Phase II Analysis Group 2 - Initial Treatment Period
- reporting Status
- POSTED
- time Frame
- Up to 2 years
- title
- Progression-free Survival (PFS) (Phase II Analysis Group 2 - Initial Treatment Period)
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice