NCT01812005 · OUTCOME
Progression-free Survival
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 from study entry to the time of progression and/or death, assessed up to 1 year
What was measured
Graphically summarized using the methods of Kaplan and Meier.
Groups in this outcome
Cohort A (Alisertib, Rituximab)
Patients receive alisertib PO BID on days 1-7. Patients unable to achieve CR after course 4 also receive rituximab IV on day 1 of courses 5-12. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. alisertib: Given PO rituximab: Given IV laboratory biomarker analysis: Laboratory correlative studies will be performed
Cohort B (Alisertib, Rituximab)
Patients receive alisertib as in Cohort A. Patients achieving SD or asymptomatic progressive disease after 2 courses also receive rituximab IV on day 1 of courses 3-10. Patients unable to achieve CR by course 4, receive rituximab as in Cohort A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. alisertib: Given PO rituximab: Given IV laboratory biomarker analysis: Laboratory correlative studies will be performed
| Group | Source count |
|---|---|
| Cohort A (Alisertib, Rituximab) | 1 |
| Cohort B (Alisertib, Rituximab) | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A (Alisertib, Rituximab) | 2 | Not reported | NA | NA | 95% Confidence Interval was incalculable due to an insufficient number of events |
| Cohort B (Alisertib, Rituximab) | 1.2 | Not reported | .8 | 2.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- 95% Confidence Interval was incalculable due to an insufficient number of events
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 2
- group Id
- OG001
- lower Limit
- .8
- upper Limit
- 2.5
- value
- 1.2
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 13
- units
- Participants
- description
- Graphically summarized using the methods of Kaplan and Meier.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive alisertib PO BID on days 1-7. Patients unable to achieve CR after course 4 also receive rituximab IV on day 1 of courses 5-12. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. alisertib: Given PO rituximab: Given IV laboratory biomarker analysis: Laboratory correlative studies will be performed
- id
- OG000
- title
- Cohort A (Alisertib, Rituximab)
- description
- Patients receive alisertib as in Cohort A. Patients achieving SD or asymptomatic progressive disease after 2 courses also receive rituximab IV on day 1 of courses 3-10. Patients unable to achieve CR by course 4, receive rituximab as in Cohort A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. alisertib: Given PO rituximab: Given IV laboratory biomarker analysis: Laboratory correlative studies will be performed
- id
- OG001
- title
- Cohort B (Alisertib, Rituximab)
- param Type
- MEDIAN
- reporting Status
- POSTED
- time Frame
- Time from study entry to the time of progression and/or death, assessed up to 1 year
- title
- Progression-free Survival
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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