NCT02293005 · 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
- From treatment start to death/progression or last follow-up, whichever come first assessed up to 25 months.
What was measured
PFS is defined as the time from the date of randomization to the date of the first documentation of progressive disease (PD) or date of death, whichever occurs first. Progression is defined using modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions or RECIST 1.1 if mRECIST cannot be used.
Analysis population: 1 patient did not complete one cycle of treatment and 25 patients were evaluable for efficacy.
Groups in this outcome
Alisertib
Alisertib was administered PO at 50 mg BID for 7 days in each treatment cycle, followed by a 14-day, treatment-free period, for a 21-day cycle.
| Group | Source count |
|---|---|
| Alisertib | 25 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Alisertib | 2.8 | Not reported | 1.3 | 4.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.3
- upper Limit
- 4.0
- value
- 2.8
- denoms
- counts
- group Id
- OG000
- value
- 25
- units
- Participants
- description
- PFS is defined as the time from the date of randomization to the date of the first documentation of progressive disease (PD) or date of death, whichever occurs first. Progression is defined using modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions or RECIST 1.1 if mRECIST cannot be used.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Alisertib was administered PO at 50 mg BID for 7 days in each treatment cycle, followed by a 14-day, treatment-free period, for a 21-day cycle.
- id
- OG000
- title
- Alisertib
- param Type
- MEDIAN
- population Description
- 1 patient did not complete one cycle of treatment and 25 patients were evaluable for efficacy.
- reporting Status
- POSTED
- time Frame
- From treatment start to death/progression or last follow-up, whichever come first assessed up to 25 months.
- title
- Progression Free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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