TriangleNCT02601209 · OUTCOME
Time to Progression (TTP) (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
- Time between randomization and disease progression, assessed up to 2 years
What was measured
Time to progression is defined as the time between randomization and disease progression. Kaplan-Meier methodology will be used to estimate the distribution of TTP. Progression (PD): At least one of the following must be true: a. At least one new malignant lesion,b. At least a 20% increase in PBSD. c. PD via FDG-PET imaging. d. unequivocal progression of existing non-target lesions and non-target lymph nodes. e. Symptomatic deterioration.
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 |
Complete source fields
- 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
- Time to progression is defined as the time between randomization and disease progression. Kaplan-Meier methodology will be used to estimate the distribution of TTP. Progression (PD): At least one of the following must be true: a. At least one new malignant lesion,b. At least a 20% increase in PBSD. c. PD via FDG-PET imaging. d. unequivocal progression of existing non-target lesions and non-target lymph nodes. e. Symptomatic deterioration.
- 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
- Time between randomization and disease progression, assessed up to 2 years
- title
- Time to Progression (TTP) (Phase II Analysis Group 2 - Initial Treatment Period)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice