TriangleNCT00306202 · OUTCOME
Number of Participants With Major Cytogenetic Response (MCyR) in Stratum 1 (Ph+ CP-CML) Within First 12 and 24 Weeks
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- After completion of Week 12 and 24 (measured at Weeks 13 and 25)
What was measured
Cytogenetic responses were based on the karyotype analysis of the percentage of Ph+ metaphases among cells in metaphase on a BM sample. At least 20 metaphase cells from a BM sample were evaluated. MCyR: A cytogenetic response that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: \>0% to 35% Ph+ cells in metaphase in BM.
Analysis population: All treated participants in stratum 1: Participants who received at least 1 dose of study therapy.
Groups in this outcome
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)
Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.
Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)
Participants with imatinib-resistant Ph+ chronic myeloid leukemia (CML) in chronic phase (CP). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.
| Group | Source count |
|---|---|
| Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2) | 11 |
| Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2) | 6 |
Reported measurements
MCyR within first 12 weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2) | 6 | Not reported | Not reported | Not reported | Not reported |
| Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2) | 2 | Not reported | Not reported | Not reported | Not reported |
MCyR within first 24 weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2) | 9 | Not reported | Not reported | Not reported | Not reported |
| Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2) | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 2
- title
- MCyR within first 12 weeks
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 5
- title
- MCyR within first 24 weeks
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- Cytogenetic responses were based on the karyotype analysis of the percentage of Ph+ metaphases among cells in metaphase on a BM sample. At least 20 metaphase cells from a BM sample were evaluated. MCyR: A cytogenetic response that was either CCyR or PCyR. CCyR: 0% Ph+ cells in metaphase in BM. PCyR: \>0% to 35% Ph+ cells in metaphase in BM.
- groups
- description
- Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.
- id
- OG000
- title
- Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)
- description
- Participants with imatinib-resistant Ph+ chronic myeloid leukemia (CML) in chronic phase (CP). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.
- id
- OG001
- title
- Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)
- param Type
- NUMBER
- population Description
- All treated participants in stratum 1: Participants who received at least 1 dose of study therapy.
- reporting Status
- POSTED
- time Frame
- After completion of Week 12 and 24 (measured at Weeks 13 and 25)
- title
- Number of Participants With Major Cytogenetic Response (MCyR) in Stratum 1 (Ph+ CP-CML) Within First 12 and 24 Weeks
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice