NCT01812005 · BASELINE
Baseline characteristics
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- denoms
- counts
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 13
- group Id
- BG002
- value
- 14
- units
- Participants
- 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
- BG000
- 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
- BG001
- title
- Cohort B (Alisertib, Rituximab)
- description
- Total of all reporting groups
- id
- BG002
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 77
- upper Limit
- 77
- value
- 77
- group Id
- BG001
- lower Limit
- 35
- upper Limit
- 73
- value
- 58
- group Id
- BG002
- lower Limit
- 35
- upper Limit
- 77
- value
- 67.5
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 3
- title
- Female
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 10
- group Id
- BG002
- value
- 11
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 13
- group Id
- BG002
- value
- 14
- title
- United States
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- patients
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 13
- group Id
- BG002
- value
- 14
- units
- Participants
- 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
- BG000
- 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
- BG001
- title
- Cohort B (Alisertib, Rituximab)
- description
- Total of all reporting groups
- id
- BG002
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 77
- upper Limit
- 77
- value
- 77
- group Id
- BG001
- lower Limit
- 35
- upper Limit
- 73
- value
- 58
- group Id
- BG002
- lower Limit
- 35
- upper Limit
- 77
- value
- 67.5
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 3
- title
- Female
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 10
- group Id
- BG002
- value
- 11
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 13
- group Id
- BG002
- value
- 14
- title
- United States
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- patients
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Preserved source evidence · Not medical advice
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