TriangleNCT00777036 · OUTCOME
Duration of Complete Cytogenetic Response (CCyR)
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 first day criteria are met for CCyR until the date of progressive disease or death (assessed up to September 2016, approximately 90 months)
What was measured
Duration of CCyR will be computed from the first day criteria are met for CCyR until the date progressive disease (PD) is reported (or treatment is discontinued for PD) or death. Participants who neither discontinue due to PD nor die will be censored on the date of their last hematologic or cytogenetic assessment, whichever comes last. (Based on \>=20 Metaphases)
Analysis population: All treated participants who achieved CCyR
Groups in this outcome
Cohort 1
Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Cohort 2
Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
Cohort 3
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
Cohort 3a
Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
Cohort 3b
Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
| Group | Source count |
|---|---|
| Cohort 1 | 24 |
| Cohort 2 | 5 |
| Cohort 3 | 79 |
| Cohort 3a | 49 |
| Cohort 3b | 30 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | NA | Not reported | 54.9 | NA | Insufficient number of participants with events |
| Cohort 2 | NA | Not reported | 1.0 | NA | Insufficient number of participants with events. |
| Cohort 3 | NA | Not reported | 49.9 | NA | Insufficient number of participants with events |
| Cohort 3a | NA | Not reported | 49.9 | NA | Insufficient number of participants with events |
| Cohort 3b | NA | Not reported | NA | NA | Insufficient number of participants with events |
Complete source fields
- classes
- categories
- measurements
- comment
- Insufficient number of participants with events
- group Id
- OG000
- lower Limit
- 54.9
- upper Limit
- NA
- value
- NA
- comment
- Insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- 1.0
- upper Limit
- NA
- value
- NA
- comment
- Insufficient number of participants with events
- group Id
- OG002
- lower Limit
- 49.9
- upper Limit
- NA
- value
- NA
- comment
- Insufficient number of participants with events
- group Id
- OG003
- lower Limit
- 49.9
- upper Limit
- NA
- value
- NA
- comment
- Insufficient number of participants with events
- group Id
- OG004
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 79
- group Id
- OG003
- value
- 49
- group Id
- OG004
- value
- 30
- units
- Participants
- description
- Duration of CCyR will be computed from the first day criteria are met for CCyR until the date progressive disease (PD) is reported (or treatment is discontinued for PD) or death. Participants who neither discontinue due to PD nor die will be censored on the date of their last hematologic or cytogenetic assessment, whichever comes last. (Based on \>=20 Metaphases)
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
- id
- OG000
- title
- Cohort 1
- description
- Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
- id
- OG001
- title
- Cohort 2
- description
- Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
- id
- OG002
- title
- Cohort 3
- description
- Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
- id
- OG003
- title
- Cohort 3a
- description
- Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
- id
- OG004
- title
- Cohort 3b
- param Type
- MEDIAN
- population Description
- All treated participants who achieved CCyR
- reporting Status
- POSTED
- time Frame
- From first day criteria are met for CCyR until the date of progressive disease or death (assessed up to September 2016, approximately 90 months)
- title
- Duration of Complete Cytogenetic Response (CCyR)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice