TriangleNCT00777036 · OUTCOME
Time to Complete Hematologic Response (CHR)
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 dose until CHR criteria are met, assessed up to September 2016 (approximately 90 months)
What was measured
Time to CHR is defined as the time from first dose of dasatinib until the first day CHR criteria are met, provided they are confirmed 4 weeks later, computed only for participants whose best response is CHR.
Analysis population: All treated participants with CHR
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 | 27 |
| Cohort 2 | 5 |
| Cohort 3 | 81 |
| Cohort 3a | 51 |
| Cohort 3b | 30 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 0.7 | Not reported | 0.5 | 1.8 | Not reported |
| Cohort 2 | 2.5 | Not reported | 0.5 | 2.8 | Not reported |
| Cohort 3 | 1.2 | Not reported | 0.9 | 1.4 | Not reported |
| Cohort 3a | 1.2 | Not reported | 0.9 | 1.4 | Not reported |
| Cohort 3b | 1.0 | Not reported | 0.7 | 1.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.5
- upper Limit
- 1.8
- value
- 0.7
- group Id
- OG001
- lower Limit
- 0.5
- upper Limit
- 2.8
- value
- 2.5
- group Id
- OG002
- lower Limit
- 0.9
- upper Limit
- 1.4
- value
- 1.2
- group Id
- OG003
- lower Limit
- 0.9
- upper Limit
- 1.4
- value
- 1.2
- group Id
- OG004
- lower Limit
- 0.7
- upper Limit
- 1.8
- value
- 1.0
- denoms
- counts
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 81
- group Id
- OG003
- value
- 51
- group Id
- OG004
- value
- 30
- units
- Participants
- description
- Time to CHR is defined as the time from first dose of dasatinib until the first day CHR criteria are met, provided they are confirmed 4 weeks later, computed only for participants whose best response is CHR.
- 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 with CHR
- reporting Status
- POSTED
- time Frame
- From first dose until CHR criteria are met, assessed up to September 2016 (approximately 90 months)
- title
- Time to Complete Hematologic Response (CHR)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice