TriangleNCT00777036 · OUTCOME
Complete Cytogenetic Response (CCyR) Rate up to 2 Years
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 24 months
What was measured
Complete Cytogenetic Response (CCyR) rate is defined as the proportion of all treated participants who achieve a CCyR while on-study. CCyR rate is defined as 0% Ph+ metaphases in at least 20 metaphases in bone marrow. The percentage of treated participants with CCyR is reported by arm.
Analysis population: All treated participants
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 | 29 |
| Cohort 2 | 17 |
| Cohort 3 | 84 |
| Cohort 3a | 51 |
| Cohort 3b | 33 |
Reported measurements
12 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 75.9 | Not reported | 56.5 | 89.7 | Not reported |
| Cohort 2 | 41.2 | Not reported | 18.4 | 67.1 | Not reported |
| Cohort 3 | 92.9 | Not reported | 85.1 | 97.3 | Not reported |
| Cohort 3a | 96.1 | Not reported | 86.5 | 99.5 | Not reported |
| Cohort 3b | 87.9 | Not reported | 71.8 | 96.6 | Not reported |
24 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 82.8 | Not reported | 64.2 | 94.2 | Not reported |
| Cohort 2 | 41.2 | Not reported | 18.4 | 67.1 | Not reported |
| Cohort 3 | 94.0 | Not reported | 86.7 | 98.0 | Not reported |
| Cohort 3a | 96.1 | Not reported | 86.5 | 99.5 | Not reported |
| Cohort 3b | 90.9 | Not reported | 75.7 | 98.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 56.5
- upper Limit
- 89.7
- value
- 75.9
- group Id
- OG001
- lower Limit
- 18.4
- upper Limit
- 67.1
- value
- 41.2
- group Id
- OG002
- lower Limit
- 85.1
- upper Limit
- 97.3
- value
- 92.9
- group Id
- OG003
- lower Limit
- 86.5
- upper Limit
- 99.5
- value
- 96.1
- group Id
- OG004
- lower Limit
- 71.8
- upper Limit
- 96.6
- value
- 87.9
- title
- 12 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 64.2
- upper Limit
- 94.2
- value
- 82.8
- group Id
- OG001
- lower Limit
- 18.4
- upper Limit
- 67.1
- value
- 41.2
- group Id
- OG002
- lower Limit
- 86.7
- upper Limit
- 98.0
- value
- 94.0
- group Id
- OG003
- lower Limit
- 86.5
- upper Limit
- 99.5
- value
- 96.1
- group Id
- OG004
- lower Limit
- 75.7
- upper Limit
- 98.1
- value
- 90.9
- title
- 24 months
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 17
- group Id
- OG002
- value
- 84
- group Id
- OG003
- value
- 51
- group Id
- OG004
- value
- 33
- units
- Participants
- description
- Complete Cytogenetic Response (CCyR) rate is defined as the proportion of all treated participants who achieve a CCyR while on-study. CCyR rate is defined as 0% Ph+ metaphases in at least 20 metaphases in bone marrow. The percentage of treated participants with CCyR is reported by arm.
- 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
- NUMBER
- population Description
- All treated participants
- reporting Status
- POSTED
- time Frame
- 24 months
- title
- Complete Cytogenetic Response (CCyR) Rate up to 2 Years
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice