TriangleNCT00075400 · OUTCOME
Progression-free Survival (PFS) > 6 Months
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow measurable disease every other cycle for the first 6 months.
What was measured
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Analysis population: Eligible and treated patients.
Groups in this outcome
Gleevec
Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
| Group | Source count |
|---|---|
| Gleevec | 23 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Gleevec | 4.3 | Not reported | 0.2 | 19.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.2
- upper Limit
- 19.0
- value
- 4.3
- denoms
- counts
- group Id
- OG000
- value
- 23
- units
- Participants
- description
- Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
- id
- OG000
- title
- Gleevec
- param Type
- NUMBER
- population Description
- Eligible and treated patients.
- reporting Status
- POSTED
- time Frame
- For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow measurable disease every other cycle for the first 6 months.
- title
- Progression-free Survival (PFS) > 6 Months
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice