TriangleNCT00777036 · OUTCOME
Rate of Best Cytogenetic Response
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
- Not reported
- Time frame
- From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
What was measured
The number of participants achieving their best on-study cytogenetic response was reported as a percentage of all treated participants in that arm. (Based on \>=20 Metaphases)
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
Complete (0%)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 82.8 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 | 29.4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3 | 94.0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3a | 96.1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3b | 90.9 | Not reported | Not reported | Not reported | Not reported |
Partial (>0% - 35%)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 6.9 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 | 23.5 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3 | 2.4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3a | 2.0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3b | 3.0 | Not reported | Not reported | Not reported | Not reported |
Minor (>35% - 65%)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 3.4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3a | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3b | 0 | Not reported | Not reported | Not reported | Not reported |
Minimal (>65% - 95%)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 3.4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3 | 1.2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3a | 2.0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3b | 0 | Not reported | Not reported | Not reported | Not reported |
No Response (>95% - 100%)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 | 5.9 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3 | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3a | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3b | 0 | Not reported | Not reported | Not reported | Not reported |
Unable to Determine
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 3.4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 | 41.2 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3 | 2.4 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3a | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3b | 6.1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 82.8
- group Id
- OG001
- value
- 29.4
- group Id
- OG002
- value
- 94.0
- group Id
- OG003
- value
- 96.1
- group Id
- OG004
- value
- 90.9
- title
- Complete (0%)
- categories
- measurements
- group Id
- OG000
- value
- 6.9
- group Id
- OG001
- value
- 23.5
- group Id
- OG002
- value
- 2.4
- group Id
- OG003
- value
- 2.0
- group Id
- OG004
- value
- 3.0
- title
- Partial (>0% - 35%)
- categories
- measurements
- group Id
- OG000
- value
- 3.4
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- Minor (>35% - 65%)
- categories
- measurements
- group Id
- OG000
- value
- 3.4
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1.2
- group Id
- OG003
- value
- 2.0
- group Id
- OG004
- value
- 0
- title
- Minimal (>65% - 95%)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 5.9
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- No Response (>95% - 100%)
- categories
- measurements
- group Id
- OG000
- value
- 3.4
- group Id
- OG001
- value
- 41.2
- group Id
- OG002
- value
- 2.4
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 6.1
- title
- Unable to Determine
- 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
- The number of participants achieving their best on-study cytogenetic response was reported as a percentage of all treated participants in that arm. (Based on \>=20 Metaphases)
- 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
- From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
- title
- Rate of Best Cytogenetic Response
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice