TriangleNCT00777036 · OUTCOME
Complete Molecular Response (CMR) Rate up to 7.5 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
- 90 months
What was measured
Molecular response will be assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). (CMR) is defined as absence of BCR-ABL rearrangements by real-time qPCR analysis. The percentage of treated participants with CMR 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 | 6.9 | Not reported | 0.8 | 22.8 | Not reported |
| Cohort 2 | 5.9 | Not reported | 0.1 | 28.7 | Not reported |
| Cohort 3 | 8.3 | Not reported | 3.4 | 16.4 | Not reported |
| Cohort 3a | 9.8 | Not reported | 3.3 | 21.4 | Not reported |
| Cohort 3b | 6.1 | Not reported | 0.7 | 20.2 | Not reported |
24 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 17.2 | Not reported | 5.8 | 35.8 | Not reported |
| Cohort 2 | 5.9 | Not reported | 0.1 | 28.7 | Not reported |
| Cohort 3 | 25.0 | Not reported | 16.2 | 35.6 | Not reported |
| Cohort 3a | 33.3 | Not reported | 20.8 | 47.9 | Not reported |
| Cohort 3b | 12.1 | Not reported | 3.4 | 28.2 | Not reported |
36 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 17.2 | Not reported | 5.8 | 35.8 | Not reported |
| Cohort 2 | 11.8 | Not reported | 1.5 | 36.4 | Not reported |
| Cohort 3 | 28.6 | Not reported | 19.2 | 39.5 | Not reported |
| Cohort 3a | 33.3 | Not reported | 20.8 | 47.9 | Not reported |
| Cohort 3b | 21.2 | Not reported | 9.0 | 38.9 | Not reported |
48 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 24.1 | Not reported | 10.3 | 43.5 | Not reported |
| Cohort 2 | 11.8 | Not reported | 1.5 | 36.4 | Not reported |
| Cohort 3 | 34.5 | Not reported | 24.5 | 45.7 | Not reported |
| Cohort 3a | 43.1 | Not reported | 29.3 | 57.8 | Not reported |
| Cohort 3b | 21.2 | Not reported | 9.0 | 38.9 | Not reported |
60 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 24.1 | Not reported | 10.3 | 43.5 | Not reported |
| Cohort 2 | 11.8 | Not reported | 1.5 | 36.4 | Not reported |
| Cohort 3 | 40.5 | Not reported | 29.9 | 51.7 | Not reported |
| Cohort 3a | 47.1 | Not reported | 32.9 | 61.5 | Not reported |
| Cohort 3b | 30.3 | Not reported | 15.6 | 48.7 | Not reported |
72 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 24.1 | Not reported | 10.3 | 43.5 | Not reported |
| Cohort 2 | 11.8 | Not reported | 1.5 | 36.4 | Not reported |
| Cohort 3 | 41.7 | Not reported | 31.0 | 52.9 | Not reported |
| Cohort 3a | 49.0 | Not reported | 34.8 | 63.4 | Not reported |
| Cohort 3b | 30.3 | Not reported | 15.6 | 48.7 | Not reported |
84 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 24.1 | Not reported | 10.3 | 43.5 | Not reported |
| Cohort 2 | 11.8 | Not reported | 1.5 | 36.4 | Not reported |
| Cohort 3 | 42.9 | Not reported | 32.1 | 54.1 | Not reported |
| Cohort 3a | 49.0 | Not reported | 34.8 | 63.4 | Not reported |
| Cohort 3b | 33.3 | Not reported | 18.0 | 51.8 | Not reported |
90 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 | 27.6 | Not reported | 12.7 | 47.2 | Not reported |
| Cohort 2 | 11.8 | Not reported | 1.5 | 36.4 | Not reported |
| Cohort 3 | 42.9 | Not reported | 32.1 | 54.1 | Not reported |
| Cohort 3a | 49.0 | Not reported | 34.8 | 63.4 | Not reported |
| Cohort 3b | 33.3 | Not reported | 18.0 | 51.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.8
- upper Limit
- 22.8
- value
- 6.9
- group Id
- OG001
- lower Limit
- 0.1
- upper Limit
- 28.7
- value
- 5.9
- group Id
- OG002
- lower Limit
- 3.4
- upper Limit
- 16.4
- value
- 8.3
- group Id
- OG003
- lower Limit
- 3.3
- upper Limit
- 21.4
- value
- 9.8
- group Id
- OG004
- lower Limit
- 0.7
- upper Limit
- 20.2
- value
- 6.1
- title
- 12 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.8
- upper Limit
- 35.8
- value
- 17.2
- group Id
- OG001
- lower Limit
- 0.1
- upper Limit
- 28.7
- value
- 5.9
- group Id
- OG002
- lower Limit
- 16.2
- upper Limit
- 35.6
- value
- 25.0
- group Id
- OG003
- lower Limit
- 20.8
- upper Limit
- 47.9
- value
- 33.3
- group Id
- OG004
- lower Limit
- 3.4
- upper Limit
- 28.2
- value
- 12.1
- title
- 24 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.8
- upper Limit
- 35.8
- value
- 17.2
- group Id
- OG001
- lower Limit
- 1.5
- upper Limit
- 36.4
- value
- 11.8
- group Id
- OG002
- lower Limit
- 19.2
- upper Limit
- 39.5
- value
- 28.6
- group Id
- OG003
- lower Limit
- 20.8
- upper Limit
- 47.9
- value
- 33.3
- group Id
- OG004
- lower Limit
- 9.0
- upper Limit
- 38.9
- value
- 21.2
- title
- 36 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.3
- upper Limit
- 43.5
- value
- 24.1
- group Id
- OG001
- lower Limit
- 1.5
- upper Limit
- 36.4
- value
- 11.8
- group Id
- OG002
- lower Limit
- 24.5
- upper Limit
- 45.7
- value
- 34.5
- group Id
- OG003
- lower Limit
- 29.3
- upper Limit
- 57.8
- value
- 43.1
- group Id
- OG004
- lower Limit
- 9.0
- upper Limit
- 38.9
- value
- 21.2
- title
- 48 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.3
- upper Limit
- 43.5
- value
- 24.1
- group Id
- OG001
- lower Limit
- 1.5
- upper Limit
- 36.4
- value
- 11.8
- group Id
- OG002
- lower Limit
- 29.9
- upper Limit
- 51.7
- value
- 40.5
- group Id
- OG003
- lower Limit
- 32.9
- upper Limit
- 61.5
- value
- 47.1
- group Id
- OG004
- lower Limit
- 15.6
- upper Limit
- 48.7
- value
- 30.3
- title
- 60 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.3
- upper Limit
- 43.5
- value
- 24.1
- group Id
- OG001
- lower Limit
- 1.5
- upper Limit
- 36.4
- value
- 11.8
- group Id
- OG002
- lower Limit
- 31.0
- upper Limit
- 52.9
- value
- 41.7
- group Id
- OG003
- lower Limit
- 34.8
- upper Limit
- 63.4
- value
- 49.0
- group Id
- OG004
- lower Limit
- 15.6
- upper Limit
- 48.7
- value
- 30.3
- title
- 72 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.3
- upper Limit
- 43.5
- value
- 24.1
- group Id
- OG001
- lower Limit
- 1.5
- upper Limit
- 36.4
- value
- 11.8
- group Id
- OG002
- lower Limit
- 32.1
- upper Limit
- 54.1
- value
- 42.9
- group Id
- OG003
- lower Limit
- 34.8
- upper Limit
- 63.4
- value
- 49.0
- group Id
- OG004
- lower Limit
- 18.0
- upper Limit
- 51.8
- value
- 33.3
- title
- 84 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12.7
- upper Limit
- 47.2
- value
- 27.6
- group Id
- OG001
- lower Limit
- 1.5
- upper Limit
- 36.4
- value
- 11.8
- group Id
- OG002
- lower Limit
- 32.1
- upper Limit
- 54.1
- value
- 42.9
- group Id
- OG003
- lower Limit
- 34.8
- upper Limit
- 63.4
- value
- 49.0
- group Id
- OG004
- lower Limit
- 18.0
- upper Limit
- 51.8
- value
- 33.3
- title
- 90 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
- Molecular response will be assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). (CMR) is defined as absence of BCR-ABL rearrangements by real-time qPCR analysis. The percentage of treated participants with CMR 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
- 90 months
- title
- Complete Molecular Response (CMR) Rate up to 7.5 Years
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice